Privacy policy

1. About this Privacy Policy

Sapyen provides reproductive health, male fertility, diagnostic, laboratory, digital health, clinical support, analytics, research and related healthcare products and services.

We recognise that reproductive and health information is personal. We also recognise that providing modern healthcare often requires information to move between patients, laboratories, healthcare professionals, technology providers and other organisations involved in delivering care.

This Privacy Policy explains how Sapyen collects, receives, creates, uses, analyses, stores, combines, derives, shares, transfers and otherwise processes information in connection with our products and services.

It also explains how information may contribute to scientific research, healthcare insights, validation studies, population reference datasets, SAGE and related analytical products, and the development and improvement of diagnostic and healthcare technologies.

For purposes of this Privacy Policy, “Sapyen,” “we,” “us” and “our” refer to Sapyen and the Sapyen entity, subsidiary or affiliate responsible for the relevant product, service or processing activity.

This Privacy Policy applies to information processed through:

  • Sapyen websites;

  • Sapyen test kits;

  • diagnostic and laboratory services;

  • patient portals;

  • clinician and clinic portals;

  • SAGE and related analytical products;

  • mobile or web applications;

  • telehealth and clinical services;

  • research programs;

  • referral services;

  • healthcare partnerships;

  • integrated partner programs;

  • customer-support services;

  • communications with Sapyen; and

  • other present or future Sapyen products and services.

Certain services may also be subject to additional notices, consents, research documentation, laboratory documentation, terms of service, cookie notices or jurisdiction-specific privacy notices.

Where a law applicable to you provides rights or protections greater than those described in this Privacy Policy, Sapyen will comply with that law.

2. Our approach to health information

The information generated through fertility and reproductive-health testing can be valuable both to the individual receiving a test and, when appropriately protected and analysed across larger populations, to scientific understanding and future healthcare.

Our approach is based on several principles.

2.1 We use information to provide the services you choose

We use relevant personal and health information to provide testing, arrange laboratory analysis, return results, coordinate healthcare, support clinicians, fulfil orders, provide consultations, operate digital services and perform other activities reasonably connected with the Sapyen service you use.

2.2 Healthcare involves multiple organisations

Depending on how you access Sapyen, your service may involve:

  • Sapyen;

  • one or more laboratories;

  • your referring provider;

  • your clinic;

  • a healthcare platform through which you obtained the test;

  • a telehealth clinician;

  • a genetic testing provider;

  • a courier or logistics provider;

  • a technology provider; and

  • other organisations needed to provide the service.

Relevant information may be provided between these organisations where necessary to deliver the service, coordinate care or fulfil the arrangement through which you obtained Sapyen testing.

2.3 You can direct us to share information

You may ask us to provide your information to a clinician, clinic, partner, spouse, family member, healthcare platform or other person or organisation.

Where you give us permission, we may provide information within the scope of that permission.

2.4 We conduct research and develop healthcare products

Subject to applicable law and appropriate safeguards, Sapyen uses information to conduct scientific research, validate existing and new technologies, develop healthcare insights, build population reference datasets, improve SAGE, develop algorithms and create new diagnostic and healthcare products.

2.5 We make extensive use of de-identified and anonymous information

Where appropriate, we remove or separate information that directly identifies an individual.

Properly anonymised or otherwise non-personal information may be retained and used for research, statistics, product development, scientific publication, benchmarking, commercial development and other lawful purposes.

2.6 We do not sell identifiable fertility results to data brokers

Sapyen does not sell identifiable semen-analysis results, genetic results, reproductive-health records or diagnostic reports to data brokers or unrelated organisations for their independent advertising or unrelated commercial exploitation.

This does not prevent Sapyen from:

  • using information to provide and improve Sapyen services;

  • providing information to organisations involved in delivering your service;

  • conducting or supporting lawful research;

  • developing and commercialising products, algorithms and insights derived from appropriately protected data;

  • working with healthcare and research partners;

  • using de-identified or anonymous information; or

  • providing identifiable information where you direct or authorise us to do so.

3. Key definitions

Privacy laws use different terminology in different countries. This Privacy Policy uses the following general terms.

3.1 Personal Information

Personal Information means information that identifies, relates to, describes or can reasonably be linked to an individual.

Depending on the jurisdiction, similar concepts may be called personal data, personally identifiable information or PII.

3.2 Health Information

Health Information means information concerning an individual's physical, reproductive, sexual, genetic, biological or other health status, healthcare, treatment, testing or related characteristics.

Depending on applicable law, this may include protected health information or PHI, consumer health data, personal health information, sensitive information or special-category personal data.

3.3 Identifiable Information

Identifiable Information means information that directly identifies an individual or can reasonably be linked back to an individual.

3.4 Pseudonymised or Coded Information

Pseudonymised Information means information from which direct identifiers have been removed or replaced, but which can still be connected to an individual using additional information.

Pseudonymised information remains personal information where applicable law treats it as such.

3.5 De-identified Information

De-identified Information means information processed to reduce the reasonable ability to associate the information with a particular individual.

The precise legal meaning of de-identification differs between jurisdictions.

3.6 Anonymous Information

Anonymous Information means information that is no longer information relating to an identified or reasonably identifiable individual under applicable law.

3.7 Aggregated Information

Aggregated Information means information combined across multiple people, samples, tests, events or records so that it principally describes a population, cohort, distribution, statistic, relationship or trend rather than a particular person.

3.8 Derived Information

Derived Information means information generated, calculated, inferred or predicted from other information.

Examples include scores, rankings, biological-age estimates, percentiles, reference classifications, risk indicators and algorithmic outputs.

4. Information we may collect and process

The information we process depends on the product or service you use.

We may process the categories below, together with other information reasonably relevant to our products, services, research or operations.

5. Identity and contact information

We may process:

  • full name;

  • preferred name;

  • date of birth;

  • age;

  • address;

  • postal code;

  • country;

  • email address;

  • telephone number;

  • sex;

  • gender where relevant;

  • account information;

  • patient identifiers;

  • laboratory identifiers;

  • order identifiers;

  • test-kit identifiers;

  • specimen identifiers;

  • healthcare identifiers;

  • signature;

  • identity-verification information;

  • authorised-representative information; and

  • other information necessary to establish, verify or manage your identity.

6. Reproductive and health information

Depending on your service, we may process information concerning:

  • fertility;

  • reproductive health;

  • semen characteristics;

  • sperm health;

  • sexual and reproductive history;

  • attempts to conceive;

  • fertility treatment;

  • assisted reproductive technology;

  • previous fertility investigations;

  • pregnancy history where relevant;

  • reproductive history involving a partner;

  • vasectomy;

  • post-vasectomy testing;

  • medical conditions;

  • diagnoses;

  • symptoms;

  • medications;

  • supplements;

  • allergies;

  • procedures;

  • surgery;

  • cancer treatment;

  • medical history;

  • family medical history;

  • hormonal information;

  • genetic history;

  • lifestyle;

  • smoking;

  • alcohol use;

  • exercise;

  • diet;

  • occupational exposures;

  • environmental exposures;

  • heat exposure;

  • substance use where clinically relevant;

  • sleep or behavioural information;

  • height;

  • weight;

  • body-mass measures;

  • other biological characteristics; and

  • other information relevant to fertility, reproductive health or the service you use.

7. Semen-analysis and laboratory information

Sapyen may process conventional and advanced laboratory measurements including:

  • semen volume;

  • sperm concentration;

  • total sperm count;

  • total motility;

  • progressive motility;

  • non-progressive motility;

  • immotile sperm;

  • total motile sperm count;

  • morphology;

  • vitality;

  • pH;

  • viscosity;

  • liquefaction;

  • appearance;

  • leukocytes;

  • round cells;

  • agglutination;

  • antisperm antibodies;

  • DNA fragmentation;

  • DNA integrity;

  • high DNA stainability;

  • oxidative stress measures;

  • epigenetic information;

  • methylation information;

  • genetic information;

  • genomic information;

  • biomarker information;

  • laboratory images;

  • microscopy information;

  • raw analytical measurements;

  • intermediate analytical outputs;

  • calculated measurements;

  • reference ranges;

  • quality-control information;

  • specimen quality;

  • sample-collection conditions;

  • collection time;

  • ejaculation or abstinence information;

  • sample-processing time;

  • transport time;

  • sample age;

  • storage information;

  • environmental conditions;

  • laboratory methodology;

  • laboratory observations;

  • laboratory comments; and

  • other existing or future reproductive-health measurements.

New diagnostic technologies may generate additional categories of information not listed above.

8. Genetic, genomic and epigenetic information

Certain Sapyen products or partner services may involve:

  • genetic variants;

  • carrier-screening information;

  • genomic information;

  • inherited-condition information;

  • epigenetic markers;

  • methylation patterns;

  • genetic risk information;

  • ancestry-related biological information where relevant to a test;

  • hereditary characteristics; and

  • other information derived from genetic material.

Genetic information may reveal information concerning both you and biological relatives.

We therefore treat identifiable genetic information as particularly sensitive and apply any additional requirements imposed by applicable law.

9. Biological specimens

Depending on the service, Sapyen or laboratories working with Sapyen may receive or handle:

  • semen;

  • blood;

  • saliva;

  • extracted DNA;

  • extracted biological material;

  • aliquots;

  • slides;

  • preserved specimens;

  • residual specimen material; and

  • derivatives created during testing.

Information obtained from biological specimens may constitute Health Information even where the specimen itself is labelled using a code or specimen number.

10. Clinical and healthcare-provider information

Where your service involves healthcare professionals, we may process:

  • referring-provider information;

  • ordering-provider information;

  • clinic information;

  • healthcare-provider notes;

  • referral information;

  • clinical history;

  • consultation notes;

  • recommendations;

  • prescriptions where applicable;

  • follow-up recommendations;

  • information concerning fertility treatment;

  • care pathways;

  • clinical communications; and

  • information exchanged between Sapyen and providers involved in your care.

11. Partner and family information

Fertility care may involve information relating to another person.

We may therefore process information concerning:

  • a spouse;

  • partner;

  • intended parent;

  • donor;

  • family member;

  • biological relative; or

  • other person involved in your reproductive healthcare.

You should only provide another person's information where you are authorised or otherwise permitted to do so.

Where necessary, Sapyen may request information or permission directly from the other individual.

12. SAGE and derived information

Sapyen may generate additional information by analysing laboratory, demographic, health or other data.

This may include:

  • SAGE scores;

  • SpermAge;

  • SpermRank;

  • fertility scores;

  • percentiles;

  • reference-population comparisons;

  • peer comparisons;

  • biological-age estimates;

  • cohort classifications;

  • expected ranges;

  • statistical predictions;

  • trends;

  • longitudinal changes;

  • calculated variables;

  • risk indicators;

  • correlations;

  • classifications;

  • predictions;

  • model outputs;

  • health insights;

  • recommendations;

  • personalised educational information; and

  • future analytical measures developed by Sapyen.

Derived information may itself be treated as Personal Information or Health Information where it can reasonably be connected to you.

13. Transaction and payment information

We may process:

  • products purchased;

  • services purchased;

  • order history;

  • subscription information;

  • billing address;

  • payment status;

  • transaction identifiers;

  • pricing;

  • discounts;

  • refunds;

  • reimbursement information;

  • health-benefit information;

  • insurance information where applicable; and

  • other information relating to payment or fulfilment.

Payment-card credentials may be collected and processed directly by payment processors rather than stored by Sapyen.

14. Communications

We may process information contained in:

  • emails;

  • telephone calls;

  • SMS messages;

  • portal messages;

  • live chats;

  • customer-service interactions;

  • questionnaires;

  • forms;

  • surveys;

  • complaints;

  • reviews;

  • social-media communications;

  • feedback;

  • telehealth communications; and

  • other interactions with Sapyen.

Where permitted by law and appropriately disclosed, calls or consultations may be recorded or transcribed for purposes such as quality, training, documentation or service delivery.

15. Technical, website and device information

When you use a Sapyen website, portal, application or electronic communication, we may process:

  • IP address;

  • browser type;

  • operating system;

  • device type;

  • device identifiers;

  • session identifiers;

  • referring website;

  • approximate geographic location;

  • login information;

  • page views;

  • navigation activity;

  • timestamps;

  • interaction events;

  • cookie identifiers;

  • analytics identifiers;

  • advertising identifiers;

  • error information;

  • performance information;

  • security logs; and

  • other technical information.

16. Research information

If you participate in research, validation, surveys, observational programs or other scientific activities, we may collect additional information relevant to the particular study.

Where additional consent, ethics approval or another legal mechanism is required, the applicable research documentation will describe the relevant activity.

17. Information concerning clinicians and business users

Sapyen may also process professional information concerning clinicians, clinics, laboratories, suppliers, research collaborators and business partners, including:

  • professional name;

  • title;

  • qualifications;

  • speciality;

  • professional registration information;

  • workplace;

  • contact information;

  • ordering history;

  • referral activity;

  • portal activity;

  • business communications;

  • contractual information; and

  • information relevant to managing our professional relationships.

18. How we obtain information

We may receive information from several sources.

18.1 Directly from you

For example, when you:

  • place an order;

  • register a test;

  • activate a kit;

  • complete a questionnaire;

  • provide a specimen;

  • create an account;

  • request a consultation;

  • communicate with us;

  • participate in research;

  • use SAGE;

  • request a referral;

  • submit feedback; or

  • otherwise use a Sapyen service.

18.2 From laboratories

Laboratories may provide:

  • test results;

  • raw analytical measurements;

  • laboratory reports;

  • quality-control information;

  • specimen information;

  • laboratory comments;

  • assay data; and

  • other information generated through testing.

18.3 From clinics and healthcare professionals

We may receive information from:

  • physicians;

  • fertility specialists;

  • GPs;

  • primary-care clinicians;

  • nurse practitioners;

  • physician assistants;

  • genetic counsellors;

  • urologists;

  • fertility clinics;

  • hospitals;

  • telehealth clinicians; and

  • other healthcare providers.

18.4 From healthcare platforms and commercial partners

Where you obtain Sapyen through another organisation, that organisation may provide information needed for Sapyen to fulfil your order or provide the service.

18.5 From another person

Your partner, authorised representative, family member or healthcare professional may provide information concerning you where permitted.

18.6 From service providers

We may receive information from organisations providing:

  • payments;

  • fulfilment;

  • logistics;

  • shipping;

  • identity verification;

  • communications;

  • software;

  • customer support; or

  • other services.

18.7 From public, licensed and research sources

For scientific, analytical and product-development activities, we may use information from:

  • scientific literature;

  • public datasets;

  • published reference ranges;

  • research databases;

  • licensed datasets;

  • academic collaborators;

  • commercial datasets;

  • healthcare organisations;

  • laboratories; and

  • other appropriately obtained sources.

18.8 Automatically

Technical information may be collected through cookies, SDKs, APIs, server logs and similar technologies.

19. Why we use information

Sapyen processes information for the purposes described below, subject to applicable law.

20. Providing Sapyen products and services

We may use information to:

  • establish your account;

  • verify your identity;

  • process an order;

  • issue or activate a test kit;

  • match an order to a specimen;

  • organise fulfilment;

  • arrange shipping;

  • arrange sample return;

  • coordinate laboratory analysis;

  • conduct testing;

  • receive laboratory results;

  • generate patient reports;

  • make reports available electronically;

  • send notifications;

  • provide SAGE;

  • provide telehealth;

  • facilitate referrals;

  • provide genetic or other partner testing;

  • respond to questions;

  • investigate an order;

  • provide customer support;

  • process payments;

  • manage subscriptions;

  • provide retesting;

  • provide follow-up services; and

  • otherwise provide the service you selected.

21. Testing and laboratory operations

We may use information to:

  • accession specimens;

  • confirm specimen identity;

  • assess specimen integrity;

  • determine whether a specimen can be tested;

  • perform testing;

  • calculate results;

  • interpret laboratory measurements;

  • investigate unusual results;

  • repeat analyses;

  • validate laboratory outputs;

  • monitor laboratory quality;

  • assess transport performance;

  • investigate delayed specimens;

  • investigate specimen-condition issues;

  • identify systematic errors;

  • perform quality control;

  • maintain laboratory documentation;

  • resolve discrepancies; and

  • satisfy clinical and laboratory obligations.

22. Returning your results and coordinating your care

A fertility test is most useful when the result can reach the people involved in your care.

Where appropriate, we may use and provide relevant information to:

  • return results to you;

  • return results to your ordering provider;

  • return results to your referring provider;

  • return results to your clinic;

  • coordinate with your fertility team;

  • discuss a result with a healthcare professional;

  • facilitate further testing;

  • facilitate a clinical consultation;

  • support continuity of care;

  • arrange referral to another provider; or

  • otherwise support the healthcare service being provided.

23. Clinicians, clinics and referring providers

Where your Sapyen test is ordered, referred, recommended, facilitated or otherwise connected with a healthcare professional or healthcare organisation, we may provide relevant information to that professional or organisation.

Recipients may include:

  • doctors;

  • general practitioners;

  • fertility specialists;

  • urologists;

  • nurse practitioners;

  • physician assistants;

  • genetic counsellors;

  • nurses;

  • allied healthcare professionals;

  • fertility clinics;

  • medical practices;

  • hospitals;

  • health systems;

  • telehealth providers; and

  • other providers involved in your care.

Depending on the arrangement, information may include:

  • your identity;

  • contact information;

  • order information;

  • specimen status;

  • laboratory status;

  • health information;

  • questionnaire responses;

  • results;

  • laboratory reports;

  • SAGE outputs;

  • follow-up information; and

  • other information reasonably relevant to your care.

Where permitted by law, this information flow may occur as part of providing and coordinating the healthcare service and may not require separate consent each time information is sent.

24. Healthcare professionals you nominate

You may ask Sapyen to provide your information to another healthcare professional.

For example, you may ask us to send your information to:

  • your GP;

  • a new fertility specialist;

  • another fertility clinic;

  • a urologist;

  • a nurse practitioner;

  • a genetic counsellor;

  • another laboratory; or

  • another healthcare professional.

Where you direct us to do so, we may provide information reasonably within the scope of your request.

We may verify your identity, the recipient or the request before providing particularly sensitive information.

25. Sapyen telehealth and clinical services

Sapyen may provide access to healthcare consultations directly or through clinicians, medical practices or telehealth organisations in our network.

These healthcare professionals may include:

  • physicians;

  • nurse practitioners;

  • genetic counsellors;

  • fertility specialists;

  • urologists; and

  • other appropriately qualified healthcare professionals.

If you request, purchase or participate in a consultation, we may provide the clinician with information reasonably relevant to the consultation, including:

  • your identity;

  • contact information;

  • medical history;

  • reproductive-health information;

  • questionnaire responses;

  • test results;

  • laboratory reports;

  • previous Sapyen results;

  • SAGE outputs; and

  • other relevant clinical information.

The clinician may create additional information during the consultation.

That information may be maintained by Sapyen, the clinician, the clinical provider or a combination of these parties depending on the service arrangement and applicable law.

26. Healthcare referrals

Sapyen may help patients identify or connect with healthcare professionals, fertility clinics, genetic counsellors or other healthcare providers.

If you ask us to arrange or facilitate a referral, we may provide the selected provider with information reasonably required to contact you or provide the requested service.

Depending on your request, this may include:

  • your name;

  • telephone number;

  • email address;

  • location;

  • reason for referral;

  • test results;

  • laboratory reports;

  • relevant health information; and

  • information concerning what type of care you are seeking.

Where full clinical information is not necessary to facilitate an initial referral, we may provide only the information needed to establish contact.

27. Products purchased through another organisation

Sometimes Sapyen testing is offered through another organisation.

Examples may include:

  • healthcare platforms;

  • digital-health services;

  • clinics;

  • fertility providers;

  • health memberships;

  • telehealth platforms;

  • diagnostic companies;

  • healthcare programs;

  • benefits providers;

  • insurers where applicable;

  • employers where applicable and appropriately authorised; and

  • other Sapyen partners.

If you obtain Sapyen through another organisation, information may need to pass between Sapyen and that organisation so the service you selected can be provided.

For example, a partner may provide Sapyen with information required to:

  • identify you;

  • fulfil your test;

  • activate your order;

  • perform testing;

  • coordinate support; or

  • associate the result with your account on the partner's platform.

Sapyen may provide the partner with information required to:

  • update order status;

  • confirm completion;

  • provide your report;

  • provide your laboratory results;

  • return relevant health information;

  • provide analytical outputs; or

  • otherwise enable the partner to deliver the service you obtained through it.

This information may include Personal Information and Health Information where those categories are reasonably required to provide the integrated service.

Where applicable law requires additional notice or consent for a particular arrangement, this may be provided during ordering, onboarding, activation or another appropriate point in the service.

A partner may have its own privacy policy governing how it independently processes information it receives.

28. Integrated partner platforms, APIs and clinical systems

Sapyen may integrate with:

  • electronic medical records;

  • electronic health records;

  • clinic-management systems;

  • laboratory-information systems;

  • patient portals;

  • healthcare APIs;

  • referral systems;

  • telehealth platforms;

  • clinical software;

  • partner applications; and

  • other health-information infrastructure.

Where you use a service involving one of these integrations, information may move electronically between systems.

This may include:

  • patient identifiers;

  • demographic information;

  • ordering information;

  • clinical information;

  • specimen status;

  • laboratory results;

  • reports;

  • health information; and

  • other information required for the integration.

These transfers may occur automatically rather than through manual transmission.

29. Service providers and contractors

Sapyen works with specialist organisations that help us provide our services.

We may provide them with information where reasonably necessary for them to perform services for Sapyen or for you.

These services may include:

  • laboratory testing;

  • pathology services;

  • specimen processing;

  • genetic testing;

  • kit manufacturing;

  • component manufacturing;

  • packaging;

  • assembly;

  • warehousing;

  • fulfilment;

  • shipping;

  • specimen transport;

  • courier services;

  • cold-chain logistics;

  • sample storage;

  • cloud infrastructure;

  • database hosting;

  • software;

  • patient portals;

  • clinician portals;

  • communications infrastructure;

  • email;

  • SMS;

  • customer support;

  • payment processing;

  • billing;

  • accounting;

  • identity verification;

  • telehealth infrastructure;

  • clinical services;

  • cybersecurity;

  • analytics;

  • data processing;

  • quality management;

  • regulatory support;

  • legal services;

  • audit services; and

  • other functions supporting Sapyen services.

Depending on what the provider does, the information may include Personal Information and Health Information.

Where appropriate, we use contractual, confidentiality, security and data-protection arrangements governing the service provider's handling of information.

30. Payment, insurance and reimbursement

Where applicable, information may be provided to organisations involved in:

  • processing payments;

  • determining benefits;

  • administering reimbursement;

  • processing insurance claims;

  • facilitating Medicare or other governmental reimbursement;

  • administering healthcare benefits; or

  • resolving payment disputes.

Only information reasonably relevant to the applicable payment, reimbursement or benefit function will be provided, subject to applicable law.

31. Sharing you request or authorise

You may request or authorise Sapyen to provide information to another person or organisation.

This may include:

  • your spouse;

  • your partner;

  • a family member;

  • your doctor;

  • a clinic;

  • a healthcare platform;

  • an insurer;

  • a benefits provider;

  • a researcher;

  • another laboratory;

  • a prospective healthcare provider;

  • a genetic counsellor;

  • another health company; or

  • another person or organisation you nominate.

Your request or permission may be provided through:

  • your account;

  • a consent form;

  • an electronic workflow;

  • email;

  • telephone;

  • written instructions;

  • a recorded interaction;

  • an online form; or

  • another method accepted by Sapyen.

Where permitted by law, we may rely on that request or permission to provide information within its reasonable scope.

32. Partners, spouses and family members

Being someone's spouse, partner or family member does not automatically provide unlimited access to their Sapyen records.

However, fertility care frequently involves couples and family members.

Where you authorise another person to participate in communications concerning your care, testing or account, Sapyen may communicate with that person within the scope of your authorisation.

You may change or withdraw an ongoing authorisation by contacting us, subject to information already disclosed and any applicable legal requirements.

33. When you include another person in a communication

You control who you include when communicating with Sapyen.

If you:

  • copy another person into an email;

  • address an email jointly to Sapyen and another person;

  • include another person in a group message;

  • introduce another person into an existing conversation;

  • ask us to contact another person;

  • forward a Sapyen conversation to someone and include us in the resulting correspondence; or

  • otherwise clearly include another person in a communication concerning your care or testing,

we may reasonably understand that you are asking us to include that person in communications concerning the subject of that conversation.

For example, if you email Sapyen about a laboratory result and copy your clinician or partner into the email, we may reply to the people included in that correspondence and discuss information reasonably relevant to your enquiry.

This does not necessarily provide that person with unlimited or permanent authority to receive every record Sapyen holds about you.

We may ask for additional confirmation where:

  • the request goes materially beyond the existing conversation;

  • particularly sensitive information is involved;

  • we are unsure whether your permission remains current;

  • the recipient's identity is uncertain; or

  • applicable law requires additional verification or consent.

If you do not want someone to receive information about your care, you should not include them in communications containing or discussing that information.

34. Authorised representatives

Where permitted by law, you may authorise another person to act for you.

This may include:

  • a legal representative;

  • attorney;

  • guardian;

  • healthcare proxy;

  • personal representative; or

  • other authorised person.

We may require evidence of their authority before providing information.

35. Operating, improving and supporting Sapyen services

We may analyse information to:

  • understand service utilisation;

  • improve patient experience;

  • investigate support issues;

  • improve reports;

  • develop educational materials;

  • evaluate turnaround time;

  • improve logistics;

  • understand failure rates;

  • identify operational bottlenecks;

  • plan inventory;

  • improve laboratory integrations;

  • evaluate customer service;

  • develop new workflows;

  • measure service quality;

  • understand patient needs;

  • evaluate product adoption; and

  • improve current or future Sapyen products and services.

36. Quality, safety and clinical performance

We may use information to:

  • monitor product performance;

  • monitor analytical performance;

  • validate tests;

  • assess accuracy;

  • evaluate specimen preservation;

  • understand transport conditions;

  • investigate product complaints;

  • investigate laboratory discrepancies;

  • assess laboratory performance;

  • conduct method-comparison studies;

  • verify reference ranges;

  • monitor safety;

  • investigate adverse events;

  • monitor manufacturing;

  • identify systematic errors;

  • improve instructions for use;

  • manage corrective and preventive actions;

  • conduct internal or external audits;

  • maintain quality systems; and

  • meet regulatory or accreditation requirements.

These activities may require reviewing identifiable patient or specimen records where necessary.

37. Scientific research

Scientific research is an important part of Sapyen's work.

Subject to applicable law and appropriate safeguards, information generated through Sapyen services may be used to expand scientific and medical understanding of fertility, reproductive biology, diagnostics, healthcare delivery and related fields.

Research may include:

  • retrospective research;

  • prospective research;

  • observational studies;

  • clinical studies;

  • analytical studies;

  • longitudinal studies;

  • epidemiological studies;

  • population studies;

  • health-services research;

  • health-economic research;

  • real-world evidence;

  • clinical validation;

  • analytical validation;

  • method-comparison studies;

  • laboratory-validation studies;

  • assay-development studies;

  • biomarker discovery;

  • biomarker validation;

  • reproductive-health research;

  • genetic research;

  • epigenetic research;

  • statistical research;

  • algorithmic research;

  • machine-learning research;

  • artificial-intelligence research;

  • healthcare-access research;

  • logistics research;

  • public-health research; and

  • other scientifically or medically relevant research.

Research may be conducted:

  • by Sapyen;

  • by Sapyen affiliates;

  • with academic institutions;

  • with universities;

  • with laboratories;

  • with hospitals;

  • with clinics;

  • with researchers;

  • with healthcare organisations;

  • with medical-device companies;

  • with biotechnology companies;

  • with pharmaceutical companies;

  • with diagnostic companies;

  • with technology companies;

  • with governmental bodies;

  • with research organisations; or

  • with other scientific collaborators.

Where identifiable or pseudonymised information is used, Sapyen will apply the legal basis, permissions and safeguards required for the relevant research activity.

38. Use of existing information for research

Information initially collected to provide Sapyen testing may also be scientifically valuable.

Where permitted by applicable law, existing information may therefore be reused for compatible or otherwise lawfully authorised:

  • scientific research;

  • statistical analysis;

  • validation;

  • quality improvement;

  • healthcare analytics;

  • product development;

  • assay development;

  • population research;

  • algorithm development; and

  • similar purposes.

Where a particular research activity requires additional consent, ethics approval or another legal authorisation, Sapyen will obtain or rely upon that mechanism as required.

39. Scientific papers, publications and conferences

Research using Sapyen information may contribute to:

  • peer-reviewed papers;

  • journal articles;

  • manuscripts;

  • scientific papers;

  • preprints;

  • research abstracts;

  • conference abstracts;

  • conference posters;

  • podium presentations;

  • scientific presentations;

  • congress presentations;

  • conference proceedings;

  • lectures;

  • workshops;

  • educational materials;

  • clinical guidelines;

  • technical papers;

  • white papers;

  • validation reports;

  • scientific reports;

  • case series where permitted;

  • regulatory materials;

  • grant applications;

  • patent applications;

  • healthcare-policy analysis; and

  • other scientific or professional communications.

Sapyen does not intend to identify individual patients in public research outputs unless:

  • the individual has specifically agreed;

  • identification is lawfully permitted; or

  • another valid legal basis applies.

Where individual-level information is used in external research materials, Sapyen will use protections appropriate to the circumstances, such as anonymisation, de-identification, pseudonymisation, aggregation, suppression, masking or other privacy-preserving techniques.

40. Development of new diagnostics and healthcare products

Subject to applicable law, information may be used to research, design, develop, prototype, train, test, validate, verify, evaluate, manufacture, improve, obtain approval for and commercialise:

  • diagnostic assays;

  • medical devices;

  • laboratory-developed tests where applicable;

  • specimen-preservation technologies;

  • collection systems;

  • fertility tests;

  • genetic tests;

  • epigenetic tests;

  • hormonal tests;

  • biomarkers;

  • digital biomarkers;

  • software;

  • health scores;

  • predictive systems;

  • clinical decision-support tools;

  • digital-health products;

  • algorithms;

  • machine-learning models;

  • artificial-intelligence systems;

  • patient reports;

  • reference ranges;

  • population benchmarks;

  • healthcare workflows;

  • telehealth products;

  • treatment-support products;

  • patient-education systems;

  • laboratory technologies; and

  • other present or future healthcare products.

Products developed through these activities may be commercialised by Sapyen, an affiliate, a collaborator, a licensee or another organisation.

41. Development of healthcare insights

Sapyen may analyse information to identify scientifically or clinically meaningful:

  • trends;

  • patterns;

  • associations;

  • relationships;

  • distributions;

  • reference ranges;

  • predictors;

  • correlations;

  • population differences;

  • longitudinal changes; and

  • other healthcare insights.

For example, analysis may examine relationships between:

  • age and semen characteristics;

  • sperm parameters and DNA fragmentation;

  • conventional semen parameters and epigenetic characteristics;

  • reproductive biomarkers and lifestyle;

  • environmental factors and reproductive health;

  • repeat testing and changes over time;

  • geographic factors and reproductive health;

  • treatment pathways and reproductive markers;

  • laboratory methodology and outcomes;

  • transport conditions and specimen characteristics;

  • genetic characteristics and reproductive measurements; and

  • other scientifically meaningful variables.

These insights may be used for:

  • scientific purposes;

  • clinical purposes;

  • educational purposes;

  • healthcare purposes;

  • product development;

  • commercial product development;

  • policy research;

  • validation;

  • benchmarking; and

  • future innovation.

42. SAGE and population benchmarking

Certain Sapyen products, including SAGE and related products, work by comparing an individual's information against information derived from larger populations.

When you use an eligible Sapyen service, eligible laboratory, demographic, health and other information may contribute, where permitted by applicable law, to reference datasets used to understand reproductive health across populations.

Reference datasets may be used to calculate or derive:

  • population distributions;

  • reference ranges;

  • percentiles;

  • rankings;

  • peer comparisons;

  • averages;

  • medians;

  • expected values;

  • correlations;

  • age-adjusted measures;

  • biological-age estimates;

  • SpermAge;

  • SpermRank;

  • SAGE scores;

  • trend estimates;

  • predictive relationships;

  • reference cohorts; and

  • other present or future analytical measures.

For example, SpermRank may evaluate where a particular result falls relative to an appropriately selected reference population.

A patient's eligible information may therefore contribute to the population against which other patients are subsequently evaluated.

Other patients are not provided access to that patient's identifiable record merely because the record contributed to the underlying reference population.

Reference populations may:

  • grow over time;

  • change as new information becomes available;

  • be segmented into different cohorts;

  • be recalibrated;

  • be combined with appropriately obtained external datasets;

  • include information from different geographical regions;

  • include different laboratory methodologies where scientifically appropriate; and

  • be used in future Sapyen analytical products.

43. Longitudinal analysis

Where permitted, Sapyen may link multiple records concerning the same individual over time.

This may allow us to understand:

  • biological variability;

  • progression over time;

  • changes following treatment;

  • changes following lifestyle modification;

  • repeatability;

  • age-related change;

  • temporal trends;

  • assay consistency;

  • health outcomes; and

  • other longitudinal relationships.

Where direct identity is unnecessary, longitudinal analysis may use coded or pseudonymised identifiers.

44. Artificial intelligence and machine learning

Sapyen may use appropriately protected information to develop, train, test and operate statistical, machine-learning or artificial-intelligence systems.

Activities may include:

  • model development;

  • model training;

  • validation;

  • calibration;

  • feature engineering;

  • bias analysis;

  • robustness testing;

  • performance evaluation;

  • reference-population development;

  • model monitoring;

  • algorithm improvement; and

  • development of new analytical outputs.

Where reasonably practicable, model-development activities will use anonymised, de-identified, aggregated or pseudonymised information rather than information that directly identifies an individual.

45. Derived models and analytical outputs

Scientific analysis can create outputs that no longer constitute a patient record.

These may include:

  • model parameters;

  • statistical coefficients;

  • algorithmic weights;

  • reference distributions;

  • population statistics;

  • correlations;

  • analytical methods;

  • mathematical functions;

  • performance metrics;

  • learned representations;

  • derived variables; and

  • other non-identifying analytical outputs.

Subject to applicable law, Sapyen may retain and use these outputs independently of the original individual records from which they were developed.

46. De-identification and anonymisation

Sapyen may de-identify, anonymise, pseudonymise, aggregate, generalise, mask, tokenise or otherwise transform information.

Techniques may include:

  • removing names;

  • removing contact information;

  • replacing identifiers;

  • assigning codes;

  • reducing geographic precision;

  • reducing date precision;

  • combining records;

  • aggregating measurements;

  • suppressing uncommon characteristics;

  • separating identifying information from research information; and

  • applying statistical or technical safeguards.

The appropriate method depends on:

  • the information;

  • the intended use;

  • available technology;

  • re-identification risk;

  • applicable law; and

  • the context in which the information will be used.

47. How we use anonymous and de-identified information

Where information has been rendered anonymous or otherwise falls outside applicable personal-information laws, Sapyen may use, retain, analyse, combine, reproduce, disclose, publish, license and commercialise that information for lawful purposes.

These purposes may include:

  • scientific research;

  • product development;

  • diagnostic development;

  • assay development;

  • population analysis;

  • healthcare analytics;

  • benchmarking;

  • SAGE;

  • machine learning;

  • artificial intelligence;

  • validation;

  • regulatory activities;

  • publication;

  • conferences;

  • education;

  • public-health research;

  • healthcare-policy research;

  • business analysis;

  • intellectual-property development;

  • commercial partnerships;

  • licensing;

  • new products; and

  • other lawful activities.

Properly anonymous or legally non-personal information may be retained for extended periods or indefinitely.

48. Research findings and intellectual property

Providing information to Sapyen does not give Sapyen ownership of you or remove any privacy rights applicable to your Personal Information.

However, research and product-development activities may create intellectual property and other valuable outputs.

Subject to applicable law, Sapyen or its licensors, collaborators or partners may own or hold rights in:

  • discoveries;

  • inventions;

  • patents;

  • patent applications;

  • algorithms;

  • software;

  • models;

  • model parameters;

  • analytical methods;

  • statistical methods;

  • reference distributions;

  • reference datasets;

  • aggregated datasets;

  • appropriately de-identified datasets;

  • correlations;

  • biomarkers;

  • methodologies;

  • assays;

  • technologies;

  • research findings;

  • scientific insights;

  • know-how;

  • product designs; and

  • other intellectual property or commercial outputs.

Research or product development involving information contributed by Sapyen users may create commercially valuable products, services, discoveries or intellectual property.

Unless Sapyen separately agrees otherwise in writing or applicable law requires otherwise, individuals whose information contributes to such work are not entitled to ownership, compensation, royalties or other payments arising from those products, findings or intellectual property.

49. Research consent and withdrawal

Where Sapyen relies on your consent for a particular research activity, you may withdraw that consent for future processing in accordance with applicable law.

Withdrawal does not:

  • make previous lawful processing unlawful;

  • require published papers to be withdrawn;

  • require completed statistical analyses to be undone;

  • necessarily require information in regulatory submissions to be removed;

  • require anonymous information to be identified and extracted;

  • require completed models to be retrained;

  • require aggregated statistics to be reconstructed; or

  • affect information Sapyen is otherwise legally permitted or required to retain.

Once information has been irreversibly anonymised, Sapyen may no longer be able to identify which information originated from you.

50. Biological specimens and residual samples

Following testing, Sapyen or a laboratory may retain residual specimen material for a period permitted or required by applicable law and laboratory policy.

Depending on the relevant service, consent and legal framework, residual specimens may be used for:

  • repeat testing;

  • confirmatory testing;

  • investigation of anomalous results;

  • laboratory quality control;

  • proficiency testing;

  • stability testing;

  • validation;

  • analytical development;

  • assay development;

  • product development;

  • research;

  • regulatory purposes; and

  • other scientifically or clinically appropriate activities.

Where a separate consent or other authorisation is required for research involving residual specimens, Sapyen or the applicable laboratory will use the required mechanism.

Specimens that are no longer required may be destroyed according to applicable laboratory procedures, contracts and legal requirements.

51. Combining information

Sapyen may combine information:

  • collected at different times;

  • obtained from multiple Sapyen tests;

  • obtained through different Sapyen services;

  • obtained from laboratories;

  • obtained from clinics;

  • obtained from healthcare providers;

  • obtained through partner platforms;

  • obtained through telehealth;

  • obtained from research studies; and

  • obtained from appropriately sourced external datasets.

Combining information may allow Sapyen to:

  • create longitudinal records;

  • improve analytical accuracy;

  • avoid duplicate records;

  • improve patient care;

  • understand relationships between different measurements;

  • improve reference populations;

  • conduct research; and

  • develop new products.

Where combined information remains identifiable, it will continue to be handled as Personal Information.

52. Record matching and duplicate resolution

Sapyen may use identifiers and other information to determine whether records relate to the same individual.

This may be necessary to:

  • match specimens;

  • link clinician orders;

  • link repeat tests;

  • connect partner orders;

  • prevent duplicate patient records;

  • resolve laboratory discrepancies;

  • associate historical results;

  • operate SAGE;

  • maintain accurate records; and

  • ensure information is returned to the correct person.

53. Regulatory and medical-device activities

Sapyen operates in regulated healthcare environments.

We may use or provide information where necessary to:

  • obtain regulatory approvals;

  • maintain regulatory approvals;

  • support registrations;

  • prepare regulatory submissions;

  • demonstrate analytical performance;

  • demonstrate clinical performance;

  • substantiate claims;

  • respond to regulators;

  • investigate adverse events;

  • conduct post-market surveillance;

  • operate quality systems;

  • maintain technical documentation;

  • conduct audits;

  • conduct corrective and preventive actions;

  • support laboratory accreditation;

  • respond to inspections; and

  • satisfy other applicable regulatory obligations.

Where identifiable patient information is not necessary, we may use appropriately protected or aggregated information.

54. Intellectual-property protection

Information may also be used where reasonably necessary to:

  • identify inventions;

  • establish inventorship;

  • support patent applications;

  • establish scientific priority;

  • demonstrate technical performance;

  • protect trade secrets;

  • prosecute intellectual-property applications;

  • defend intellectual property; and

  • enforce Sapyen's rights.

Public patent or technical materials will not intentionally identify individual patients unless identification is authorised or otherwise legally permitted.

55. Research collaborators

Sapyen may collaborate with:

  • universities;

  • academic researchers;

  • hospitals;

  • research institutes;

  • laboratories;

  • fertility clinics;

  • medical-device companies;

  • biotechnology companies;

  • pharmaceutical companies;

  • diagnostic companies;

  • healthcare companies;

  • technology organisations;

  • government agencies;

  • research consortia; and

  • other scientific organisations.

Where practical and appropriate, collaborators will receive:

  • anonymous information;

  • de-identified information;

  • aggregated information; or

  • pseudonymised information

instead of directly identifying information.

Identifiable information may be provided where the particular activity permits or requires it and the necessary legal basis, permissions, consent, ethics approval, contractual protections or other safeguards are in place.

56. Marketing and communications

Subject to applicable law, Sapyen may use contact and engagement information to:

  • communicate about your order;

  • provide service updates;

  • provide educational information;

  • recommend relevant Sapyen products;

  • inform you about new tests;

  • communicate offers;

  • invite feedback;

  • invite participation in research;

  • invite you to retest;

  • provide health education;

  • communicate relevant services;

  • promote Sapyen products; and

  • measure communications.

Where required, marketing communications will be sent only with the appropriate consent.

You may unsubscribe from marketing communications using the unsubscribe mechanism provided or by contacting Sapyen.

Service communications concerning an active order, account, test, safety issue, result or other operational matter may still be sent where necessary.

57. Advertising and health information

Sapyen may use advertising and analytics services on public-facing websites and marketing pages.

We recognise that authenticated patient portals, laboratory results and other clinical information require different treatment.

We do not intentionally disclose identifiable laboratory results, genetic results or detailed reproductive-health records to advertising platforms for their independent advertising purposes without the permission required by applicable law.

Where advertising or analytics technology could constitute a sale, sharing, targeted advertising or another regulated activity under applicable law, Sapyen will provide the consent or opt-out mechanism required for that jurisdiction.

58. Cookies and similar technologies

Sapyen may use:

  • cookies;

  • pixels;

  • tags;

  • local storage;

  • SDKs;

  • analytics tools;

  • server-side analytics;

  • attribution tools; and

  • similar technologies.

These may be used to:

  • operate websites;

  • authenticate users;

  • remember preferences;

  • maintain sessions;

  • protect security;

  • prevent fraud;

  • diagnose technical problems;

  • measure website performance;

  • understand use of Sapyen services;

  • improve websites;

  • attribute marketing;

  • measure campaigns;

  • personalise content; and

  • support other legitimate website functions.

Where required by law, non-essential cookies and tracking technologies will be used only after the necessary consent has been obtained.

59. Business analytics

Sapyen may use information to understand and operate its business.

This may include analysing:

  • order volume;

  • product use;

  • test uptake;

  • conversion;

  • customer support;

  • market demand;

  • geographic demand;

  • clinic adoption;

  • referral patterns;

  • operational performance;

  • supply-chain performance;

  • revenue;

  • product utilisation;

  • cohort behaviour;

  • retention;

  • laboratory performance; and

  • other business metrics.

Where individual identity is not necessary for an analysis, we may use aggregated or de-identified information.

60. Fraud, misuse and security

We may use information to:

  • verify identity;

  • detect fraud;

  • investigate suspicious activity;

  • protect patient accounts;

  • identify misuse;

  • enforce service limits;

  • prevent unauthorised access;

  • maintain cybersecurity;

  • investigate security incidents;

  • monitor system integrity;

  • protect laboratories and partners; and

  • maintain the safety and integrity of Sapyen services.

61. Legal claims and disputes

We may process or provide information where reasonably necessary to:

  • investigate complaints;

  • resolve disputes;

  • obtain legal advice;

  • respond to legal claims;

  • enforce agreements;

  • recover debts;

  • establish legal rights;

  • exercise legal rights;

  • defend legal rights;

  • comply with court processes;

  • preserve evidence; and

  • respond to lawful legal demands.

62. Regulators, accreditation bodies and government authorities

We may provide information to:

  • health regulators;

  • medical-device regulators;

  • laboratory regulators;

  • accreditation bodies;

  • privacy regulators;

  • public-health authorities;

  • law-enforcement agencies;

  • courts;

  • tribunals;

  • government agencies; and

  • other competent authorities

where required or permitted by applicable law.

63. Emergencies and safety

Where permitted by law, Sapyen may use or provide information where reasonably necessary to respond to:

  • a serious threat to life;

  • a serious threat to health;

  • an emergency;

  • suspected abuse where reporting obligations apply;

  • public-health requirements; or

  • another situation in which disclosure is legally permitted to protect a person.

64. Professional advisers

We may provide relevant information to professional advisers including:

  • lawyers;

  • accountants;

  • auditors;

  • insurers;

  • consultants;

  • compliance advisers;

  • cybersecurity advisers;

  • quality advisers; and

  • regulatory advisers

where reasonably necessary for them to provide professional services.

65. Corporate transactions

If Sapyen considers or undertakes:

  • an investment;

  • financing;

  • merger;

  • acquisition;

  • reorganisation;

  • joint venture;

  • sale of assets;

  • sale of a business;

  • insolvency process;

  • restructuring; or

  • similar corporate transaction,

information may be made available to prospective or actual investors, purchasers, lenders, advisers or counterparties where reasonably necessary for the transaction.

Where individual patient information is unnecessary, Sapyen may use aggregated or de-identified information.

Where Personal Information is involved, confidentiality, security and legal protections will be applied as appropriate.

If Sapyen or part of Sapyen is acquired, Personal Information associated with the transferred business may form part of that transaction and may be transferred to the successor organisation where permitted by law.

66. Independent responsibilities of clinics, laboratories and partners

Organisations participating in a Sapyen service do not always have the same legal role.

Depending on the arrangement:

  • Sapyen may determine how information is processed;

  • another organisation may process information only on Sapyen's instructions;

  • a clinic may independently determine how it processes clinical information;

  • a laboratory may have independent legal duties concerning laboratory records;

  • a telehealth provider may independently maintain medical records;

  • a partner platform may independently determine how it provides its healthcare service; or

  • two organisations may jointly determine certain processing activities.

As a result, another organisation may provide you with its own privacy policy.

That organisation's policy may apply to its independent processing of your information.

67. Information we receive from third parties

Where another organisation provides information concerning you to Sapyen, we may rely on the organisation to have the authority required to provide that information where appropriate.

We may use information received from third parties for the purposes for which it was provided and for other purposes described in this Privacy Policy where legally permitted.

68. Information about other people that you provide

If you provide Sapyen with Personal Information concerning another person, you represent that you are permitted to provide that information where such permission is required.

Examples may include information concerning:

  • your partner;

  • spouse;

  • family member;

  • clinician;

  • intended parent; or

  • authorised representative.

We may contact the other individual directly where necessary.

69. Automated analysis and decision support

Certain Sapyen products may use automated systems to generate:

  • calculations;

  • scores;

  • classifications;

  • percentiles;

  • reference comparisons;

  • predictions;

  • recommendations;

  • risk indicators; or

  • other analytical outputs.

These systems may use:

  • predefined clinical rules;

  • statistical techniques;

  • algorithms;

  • machine-learning systems;

  • artificial-intelligence systems; or

  • combinations of these approaches.

Where applicable law provides rights concerning decisions based solely on automated processing that produce legal or similarly significant effects, Sapyen will provide those rights.

Unless expressly stated otherwise, Sapyen analytical outputs are not intended to replace individual medical advice from an appropriately qualified healthcare professional.

70. Future technologies and services

Healthcare technology evolves.

Sapyen may introduce new:

  • tests;

  • biomarkers;

  • genetic analyses;

  • epigenetic analyses;

  • hormonal analyses;

  • imaging systems;

  • scores;

  • digital biomarkers;

  • artificial-intelligence tools;

  • machine-learning systems;

  • clinical services;

  • telehealth products;

  • reports;

  • healthcare integrations; and

  • diagnostic technologies.

Information already lawfully held by Sapyen may, where permitted by applicable law and consistent with this Privacy Policy, be used to evaluate, research, validate, develop or improve new technologies and services.

If a materially different activity requires new notice or consent under applicable law, we will provide that notice or seek that consent.

71. Legal bases for processing

The legal basis on which Sapyen processes Personal Information depends on:

  • the jurisdiction;

  • the information;

  • the service;

  • Sapyen's legal role;

  • the purpose of processing; and

  • other relevant circumstances.

Where applicable, Sapyen may rely on one or more of the following:

  • performance of a contract;

  • steps requested before entering a contract;

  • consent;

  • explicit consent;

  • provision of healthcare;

  • medical diagnosis;

  • treatment;

  • management of healthcare services;

  • compliance with legal obligations;

  • legitimate interests;

  • public-health grounds;

  • scientific research;

  • statistical purposes;

  • substantial public interest;

  • protection of vital interests;

  • establishment, exercise or defence of legal claims; and

  • other grounds authorised by applicable law.

More than one legal basis may apply to a particular activity.

72. Sensitive and special-category information

Health, genetic, reproductive and sexual-health information may receive additional legal protection.

Where an additional condition is required to process such information, Sapyen will rely on an applicable condition such as:

  • explicit consent;

  • healthcare;

  • medical diagnosis;

  • management of healthcare systems;

  • scientific research;

  • public health;

  • substantial public interest;

  • legal claims;

  • vital interests; or

  • another condition available under applicable law.

73. Consent

Where we rely on consent, consent may be obtained:

  • electronically;

  • through an account;

  • through an activation process;

  • through a written form;

  • through an online consent;

  • verbally where permitted and appropriately recorded; or

  • using another method recognised by applicable law.

We may request separate consent for matters including:

  • research;

  • genetic testing;

  • use of residual specimens;

  • certain partner disclosures;

  • marketing;

  • particular consumer-health-data uses;

  • certain international transfers; and

  • activities for which specific consent is legally required.

Where applicable, consent can be withdrawn prospectively.

74. International operations

Sapyen operates internationally.

Depending on the service you use, information may be:

  • collected in one country;

  • stored in another;

  • processed in another;

  • accessed by authorised personnel in another; or

  • provided to a laboratory or service provider in another.

Countries in which Sapyen information may be processed can include:

  • Australia;

  • the United States;

  • the United Kingdom;

  • countries within the European Economic Area;

  • Canada; and

  • other countries in which Sapyen or organisations supporting Sapyen operate.

75. International data transfers

Where applicable law restricts international transfers, Sapyen uses a legally recognised transfer mechanism or other lawful basis.

Depending on the jurisdiction and circumstances, these may include:

  • adequacy decisions;

  • adequacy regulations;

  • Standard Contractual Clauses;

  • the UK International Data Transfer Agreement;

  • the UK Addendum;

  • contractual safeguards;

  • transfer assessments;

  • binding arrangements;

  • explicit consent where legally appropriate;

  • transfers necessary for services requested by an individual;

  • legal exceptions; and

  • other mechanisms recognised by applicable law.

76. Data localisation

Sapyen may maintain regional infrastructure where:

  • required by law;

  • required by contract;

  • appropriate for security;

  • appropriate for healthcare operations; or

  • operationally appropriate.

Regional storage does not necessarily mean information can never be accessed from another country.

For example, authorised personnel may need to access information for:

  • technical support;

  • security;

  • quality;

  • research;

  • regulatory activities; or

  • other legitimate operational purposes

where such access is permitted and appropriately protected.

77. Storage and retention

Sapyen retains Personal Information for as long as reasonably necessary for the purposes for which it was collected or subsequently lawfully processed.

Retention may depend on:

  • healthcare-record requirements;

  • laboratory requirements;

  • medical-device regulation;

  • quality systems;

  • accreditation requirements;

  • product-safety requirements;

  • research needs;

  • scientific integrity;

  • regulatory obligations;

  • statutory limitation periods;

  • taxation;

  • financial reporting;

  • contracts;

  • dispute resolution;

  • fraud prevention;

  • cybersecurity;

  • ongoing patient services;

  • clinical requirements; and

  • other legitimate business or legal requirements.

Different categories of information may therefore be retained for different periods.

78. Research retention

Information used for scientific research, historical research, validation or statistical purposes may be retained for longer periods where permitted by applicable law and appropriate safeguards are maintained.

Long-term retention may be scientifically important for:

  • longitudinal analysis;

  • reproducibility;

  • validation;

  • regulatory requirements;

  • scientific integrity;

  • comparison of historical and future data; and

  • development of reference populations.

79. Retention of anonymous information

Properly anonymous, aggregated or otherwise non-personal information may be retained indefinitely where permitted by applicable law.

80. Security

Sapyen uses technical, physical, administrative and organisational measures designed to protect Personal Information against:

  • unauthorised access;

  • unauthorised disclosure;

  • alteration;

  • destruction;

  • accidental loss;

  • misuse; and

  • other security threats.

Depending on the system and risk, measures may include:

  • encryption;

  • role-based access;

  • authentication;

  • access logging;

  • monitoring;

  • network security;

  • staff training;

  • confidentiality obligations;

  • vendor security assessment;

  • secure software-development practices;

  • backup systems;

  • incident-response procedures;

  • business-continuity processes;

  • physical controls; and

  • contractual safeguards.

No technical or organisational system can guarantee absolute security.

81. Data incidents

If Sapyen becomes aware of a privacy or security incident involving Personal Information, we will investigate the incident and take appropriate steps.

Where applicable law requires notification to individuals, regulators or other organisations, Sapyen will provide the required notification.

82. Your privacy rights

Your rights depend on the law that applies to you.

Depending on your jurisdiction, you may have a right to:

  • know whether Sapyen processes information about you;

  • access information;

  • obtain a copy;

  • request correction;

  • request deletion;

  • request erasure;

  • restrict processing;

  • object to processing;

  • withdraw consent;

  • request portability;

  • opt out of certain marketing;

  • opt out of certain targeted advertising;

  • opt out of certain sales or sharing;

  • limit certain processing of sensitive information;

  • request information concerning automated processing;

  • appeal certain privacy decisions;

  • nominate an authorised agent; and

  • complain to a regulator.

These rights are subject to applicable exceptions.

83. When information cannot be deleted

A request for deletion does not necessarily require Sapyen to remove every record.

We may retain information where permitted or required for purposes including:

  • medical records;

  • laboratory records;

  • regulatory obligations;

  • device safety;

  • quality systems;

  • legal claims;

  • contractual obligations;

  • fraud prevention;

  • security;

  • accounting;

  • scientific research;

  • preservation of scientific integrity; and

  • other lawful purposes.

Information that has already been properly anonymised may no longer be attributable to you and therefore may not be capable of being identified for deletion.

84. Exercising your rights

To exercise a privacy right, contact:

compliance@sapyen.co

We may need to verify your identity before acting on a request.

Where an authorised agent makes a request, we may request evidence of their authority.

We will respond within the period required by applicable law.

85. European Economic Area

Where the EU General Data Protection Regulation applies, Sapyen processes personal data in accordance with applicable GDPR requirements.

Health data, genetic data and certain information relating to sex life may constitute special-category personal data.

Where required, Sapyen identifies:

  1. an applicable lawful basis for processing personal data; and

  2. an applicable condition for processing special-category data.

Depending on the processing activity, relevant bases or conditions may include:

  • contract;

  • consent;

  • explicit consent;

  • legitimate interests;

  • healthcare;

  • medical diagnosis;

  • management of healthcare services;

  • scientific research;

  • public health;

  • legal obligations;

  • legal claims; and

  • other grounds permitted by applicable law.

Scientific research involving personal data will use safeguards appropriate to the activity.

Where possible and appropriate, research may use anonymised, pseudonymised or otherwise privacy-protected information.

EEA residents may have rights including:

  • access;

  • rectification;

  • erasure;

  • restriction;

  • portability;

  • objection;

  • withdrawal of consent; and

  • rights concerning certain automated decisions.

You may also lodge a complaint with the competent supervisory authority in the EEA country in which you live, work or believe an infringement occurred.

86. EEA research and scientific processing

European data-protection law recognises scientific research and statistical processing subject to applicable requirements and safeguards.

Where Sapyen relies on scientific-research provisions, we will apply appropriate safeguards, which may include:

  • data minimisation;

  • pseudonymisation;

  • separation of identifiers;

  • access controls;

  • confidentiality;

  • technical security; and

  • use of anonymous information where practicable.

Where consent is the appropriate basis for a specific study or activity, the relevant consent will explain that activity.

87. United Kingdom

Where UK data-protection law applies, Sapyen processes Personal Information in accordance with applicable UK requirements.

Health, genetic and certain reproductive information may constitute special-category information.

Sapyen may process such information where an appropriate lawful basis and special-category condition apply.

Depending on the circumstances, this may include:

  • healthcare;

  • diagnosis;

  • scientific research;

  • explicit consent;

  • public health;

  • legal claims; and

  • other conditions recognised by UK law.

UK residents may have rights including:

  • access;

  • correction;

  • erasure;

  • restriction;

  • portability;

  • objection;

  • withdrawal of consent; and

  • rights relating to certain automated decisions.

UK residents may complain to the Information Commissioner's Office.

88. UK research

UK data-protection law contains provisions supporting scientific research, statistical purposes and certain related processing where applicable requirements and safeguards are met.

Sapyen may use those provisions where appropriate.

Research safeguards may include:

  • minimisation;

  • pseudonymisation;

  • confidentiality controls;

  • separation of identifiers;

  • security controls; and

  • use of anonymous data where practicable.

89. Australia

Where Australia's Privacy Act 1988 and Australian Privacy Principles apply, Sapyen processes Personal Information in accordance with those requirements.

Health and genetic information generally constitute sensitive information.

Depending on the circumstances, Sapyen may use or disclose Personal Information where:

  • the use or disclosure is for the primary purpose for which it was collected;

  • a secondary purpose is appropriately related to the primary purpose and within reasonable expectations where the law permits;

  • you consent;

  • the processing falls within an applicable permitted health situation;

  • it is required or authorised by law; or

  • another legal basis or exception applies.

Healthcare-related information may be used or provided as reasonably necessary to deliver and coordinate the health service you obtain through Sapyen, subject to applicable law.

90. Australian research

Australian privacy law provides mechanisms under which health information may, in specified circumstances, be used or disclosed for research or statistical activities relevant to public health or public safety.

Where Sapyen relies on such a mechanism, we will comply with the applicable requirements.

Research may also be undertaken:

  • with consent;

  • using de-identified information;

  • under another lawful research framework; or

  • using another basis permitted by applicable law.

Australian residents may request access to or correction of Personal Information.

You may raise a privacy complaint with Sapyen and, where applicable, with the Office of the Australian Information Commissioner or another competent regulator.

91. Canada

Where Canadian privacy law applies, Sapyen will comply with applicable federal and provincial privacy requirements.

Canadian privacy requirements may arise under:

  • federal private-sector privacy legislation;

  • provincial private-sector privacy legislation;

  • provincial personal-health-information legislation; or

  • a combination of these frameworks.

Health, genetic and reproductive information is generally highly sensitive.

The type of consent or other legal authority required may depend on:

  • the province;

  • the sensitivity of the information;

  • the purpose;

  • the healthcare relationship;

  • reasonable expectations; and

  • the applicable statutory framework.

92. Canadian consent

Where consent is required under Canadian privacy law, Sapyen will use a form of consent appropriate to the circumstances.

Because health information is sensitive, express consent may be required for activities outside a person's reasonable expectations.

Implied consent may be appropriate in more limited circumstances where the context clearly supports the information flow and applicable law permits it.

Canadian residents may have rights to:

  • access Personal Information;

  • correct Personal Information;

  • withdraw consent where applicable;

  • challenge Sapyen's privacy practices; and

  • complain to the applicable federal or provincial privacy regulator.

93. United States

Privacy law in the United States depends on:

  • the state;

  • the information;

  • the organisation;

  • the healthcare relationship;

  • the type of service; and

  • the legal role in which Sapyen is operating.

Sapyen information may be subject to:

  • federal consumer-protection laws;

  • federal health privacy requirements;

  • state consumer-privacy laws;

  • state consumer-health-data laws;

  • genetic privacy laws;

  • medical-record laws;

  • laboratory laws;

  • breach-notification laws; and

  • other healthcare requirements.

94. HIPAA

Not every health product, health application or diagnostic service is subject to the Health Insurance Portability and Accountability Act of 1996, commonly known as HIPAA.

Where Sapyen or an organisation involved in your service is acting in a capacity subject to HIPAA, the applicable HIPAA requirements will apply to that information and activity.

Where Sapyen is acting as a business associate of a HIPAA covered entity, information may also be processed in accordance with the applicable business associate agreement.

Where HIPAA does not apply, other federal and state privacy and consumer-protection laws may still protect health information.

Nothing in this Privacy Policy should be interpreted as representing that every Sapyen product, record or activity is subject to HIPAA.

95. United States healthcare operations

Where HIPAA applies to a particular service, permitted uses and disclosures may include activities involving:

  • treatment;

  • healthcare coordination;

  • referral;

  • payment;

  • quality assessment;

  • healthcare operations;

  • legal and compliance functions; and

  • other activities permitted by HIPAA.

Where required, additional HIPAA notices or authorisations may apply.

96. United States consumer health data

Certain states regulate consumer health information even where HIPAA does not apply.

Depending on applicable law, consumer health data may include:

  • reproductive-health information;

  • laboratory information;

  • genetic information;

  • measurements of bodily functions;

  • inferred health information;

  • information concerning treatment;

  • information concerning procedures; and

  • other health-related data.

Where a state consumer-health-data law requires:

  • consent;

  • separate consent for sharing;

  • a specific authorisation for sale;

  • a dedicated privacy notice;

  • deletion rights;

  • access rights;

  • withdrawal rights; or

  • other protections,

Sapyen will provide the required mechanism.

97. California

Where the California Consumer Privacy Act applies, California residents may have rights including:

  • the right to know;

  • the right to access;

  • the right to correct;

  • the right to delete;

  • the right to opt out of certain sales or sharing;

  • the right to limit certain uses of sensitive Personal Information; and

  • the right not to receive discriminatory treatment for exercising protected privacy rights.

California law treats certain categories including health information and genetic data as sensitive Personal Information.

Sapyen will provide legally required California mechanisms where applicable.

98. Other United States state privacy laws

Other states provide rights concerning Personal Information, sensitive information, targeted advertising, profiling, health information or genetic data.

Where applicable, Sapyen will provide the rights and opt-out mechanisms required by the relevant state law.

99. Washington consumer health data

Washington's My Health My Data framework regulates certain consumer health data that may fall outside HIPAA.

Where that law applies, Sapyen will provide the notices, consents and rights required by the legislation.

This may include rights concerning:

  • collection;

  • sharing;

  • access;

  • deletion;

  • withdrawal of consent; and

  • sale of consumer health data.

Where required, Sapyen will provide a separate Washington Consumer Health Data Privacy Policy or other dedicated notice.

100. Sale and sharing under United States privacy laws

Some United States privacy laws define words such as “sale” and “sharing” more broadly than their ordinary meaning.

For example, an activity can potentially constitute regulated sharing even where Personal Information is not literally sold for money.

Where Sapyen engages in an activity legally defined as a sale, sharing or targeted-advertising activity, we will provide the rights, consent or opt-out mechanism required by applicable law.

101. Global Privacy Control

Where Sapyen is legally required to recognise Global Privacy Control or another legally recognised browser-based universal opt-out signal, we will process that signal in accordance with applicable law.

Such signals may be browser-specific or device-specific.

102. Children and minors

Sapyen's direct-to-consumer fertility services are generally intended for adults.

We do not knowingly collect Personal Information from children through adult-only services except where:

  • the service is legally available to a minor;

  • the service is ordered through an appropriate healthcare professional;

  • a parent or guardian is appropriately involved;

  • consent or authorisation has been obtained where required; or

  • another lawful basis applies.

If you believe information relating to a child has been collected inappropriately, contact us.

103. Third-party websites and services

Sapyen websites or applications may link to websites or services operated by other organisations.

Those organisations may independently collect and process information.

Their own privacy policies apply to their independent activities.

Sapyen is not responsible for the independent privacy practices of third-party websites merely because a link is available through a Sapyen service.

104. Social media

If you interact with Sapyen through a social-media platform, the platform may independently process information concerning your activity.

You should review the privacy practices of the relevant platform.

Information you intentionally make public through social media may be visible to other users.

105. Confidentiality of test results

Sapyen recognises that fertility, semen, reproductive, genetic and related information can be sensitive.

Identifiable test results are made available only where appropriate to provide or support the relevant service or where otherwise authorised or permitted.

Recipients may include:

  • you;

  • your authorised representative;

  • an ordering healthcare provider;

  • a referring healthcare provider;

  • your clinic;

  • a laboratory;

  • Sapyen personnel who require access;

  • a clinician providing a consultation;

  • a healthcare platform through which you obtained the service;

  • another recipient you nominate; or

  • another person or organisation where disclosure is legally permitted or required.

106. Re-identification

Where Sapyen holds or provides information in a form subject to a legal or contractual requirement not to re-identify individuals, Sapyen will comply with that restriction.

There may be limited circumstances in which controlled re-identification is legally permitted or scientifically necessary, such as:

  • validating a de-identification method;

  • investigating data quality;

  • correcting patient records;

  • protecting patient safety;

  • responding to a legal requirement; or

  • another authorised purpose.

Appropriate controls will be used where such activity is undertaken.

107. Accuracy

Sapyen takes reasonable steps appropriate to the circumstances to maintain information that is sufficiently accurate for the purpose for which it is used.

Healthcare information can change over time.

You should notify Sapyen or your healthcare provider if you believe information relevant to your care is materially inaccurate.

Laboratory results represent measurements generated from the relevant specimen at the relevant time and ordinarily will not be altered merely because a later test produces a different result.

108. Changes to this Privacy Policy

Sapyen may update this Privacy Policy as:

  • laws change;

  • regulatory requirements change;

  • our technology develops;

  • new products are introduced;

  • new research activities begin;

  • our service-provider relationships change;

  • Sapyen enters new markets;

  • our healthcare partnerships evolve; or

  • our business develops.

The effective date at the beginning of this Privacy Policy identifies the date of the current version.

Where applicable law requires additional notice or consent for a material change in processing, Sapyen will provide that notice or obtain that consent.

109. Contacting Sapyen

Questions, concerns, privacy requests and complaints may be directed to:

Sapyen Privacy Team / Data Protection Officer

Sapyen
Level 22, 120 Spencer Street
Melbourne VIC 3000
Australia

Email: compliance@sapyen.co
Website: sapyen.co
Telephone: +61 2 5604 0105

Where required by applicable law, Sapyen may separately identify a local privacy representative, data-protection representative or responsible Sapyen entity.

110. Complaints

If you have a concern about how Sapyen handles Personal Information, please contact us so we can investigate.

Depending on where you live, you may also have a right to complain to a competent privacy, health or consumer-protection regulator.

This may include:

  • a European Economic Area data-protection authority;

  • the United Kingdom Information Commissioner's Office;

  • the Office of the Australian Information Commissioner;

  • an Australian state or territory regulator where applicable;

  • the Office of the Privacy Commissioner of Canada;

  • a Canadian provincial privacy commissioner;

  • a United States state attorney general;

  • the California Privacy Protection Agency; or

  • another competent regulator.

You may contact compliance@sapyen.co if you require information about the privacy process relevant to your Sapyen service.

Effective Date: 19 August 2026

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