Privacy Notice for PXD Limited

(trading as Explantlab)

For the MyOrthotypeTM test

1. What is the purpose of this document? 1

2. Data protection principles 1

3. The kind of information we hold about you 2

4. How is your personal information collected? 2

5. How we will use information about you 3

6. Situations in which we will use your personal information 3

7. If you fail to provide personal information 4

8. Change of purpose 4

9. How we use particularly sensitive personal information 4

10. Situations in which we will use your sensitive personal information 5

11. Do we need your consent? 5

12. Automated decision-making 6

13. Data sharing 6

14. Transferring information outside the UK 7

15. Data security 8

16. Data retention 8

1. What is the purpose of this document?

PXD Limited (trading as Explantlab) (Explantlab) with registered number 07483251 whose address is at The Biosphere, Draymans Way, Newcastle Upon Tyne, NE4 5BX is committed to protecting the privacy and security of your personal information.

This privacy notice describes how we collect and use personal information about you, in accordance with the UK General Data Protection Regulation (UK GDPR).

It applies to all patients who consent to MyOrthotypeTM testing.

Explantlab is a "controller". This means that we are responsible for deciding how we hold and use personal information about you. We are required under data protection legislation to notify you of the information contained in this privacy notice.

This notice applies to current and former patients. This notice does not form part of any other contract. We may update this notice at any time but if we do so, we will provide you with an updated copy of this notice as soon as reasonably practical.

It is important that you read and retain this notice, together with any other privacy notice we may provide on specific occasions when we are collecting or processing personal information about you, so that you are aware of how and why we are using such information and what your rights are under the data protection legislation.

2. Data protection principles

We will comply with data protection law. This says that the personal information we hold about you must be:

2.1 Used lawfully, fairly and in a transparent way.

2.2 Collected only for valid purposes that we have clearly explained to you and not used in any way that is incompatible with those purposes.

2.3 Relevant to the purposes we have told you about and limited only to those purposes.

2.4 Accurate and kept up to date.

2.5 Kept only as long as necessary for the purposes we have told you about.

2.6 Kept securely.

3. The kind of information we hold about you

Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data).

There are certain types of more sensitive personal data which require a higher level of protection, such as information about a person's health or sexual orientation. Information about criminal convictions also warrants this higher level of protection.

As part of the MyOrthotypeTM testing process, we will routinely collect, store, and use the following categories of personal information about you:

· Personal contact details such as name, title, addresses, telephone numbers, and personal email addresses.

· Date of birth.

· Gender.

· Genotype DNA details.

If you also consent to be involved in further research, if you give us your permission, we will also collect, store and use the following categories of personal information about you:

· Ethnicity.

· Hospital number.

· NHS number.

· National Joint registry number.

· Details of any medical conditions.

· Implant details (such as the type of implant and the date of your surgeries to help us determine the age of your implant).

· Blood metal concentration reading levels.

· +/- contact details.

· Genetic information and biometric data.

4. How is your personal information collected?

We collect personal information about you either directly when you provide buccal swab or saliva samples for MyOrthotypeTM testing or via authorised licensee  (such as an NHS Trust) of MyOrthotypeTM.

5. How we will use information about you

We will only use your personal information when the law allows us to. Most commonly, we will use your personal information in the following circumstances:

5.1 Where we need to perform the contract we have entered into with you.

5.2 Where we need to comply with a legal obligation.

5.3 Where it is necessary for legitimate interests pursued by us or a third party and your interests and fundamental rights do not override those interests.

5.4 Where you have consented for us to store your contact details in order for us to contact you in the future to consider taking part in further ethically approved research.

We may also use your personal information in the following situations, which are likely to be rare:

5.5 Where we need to protect your interests (or someone else's interests).

5.6 Where it is needed in the public interest or for official purposes.

6. Situations in which we will use your personal information

We need all the categories of information in the list above primarily to allow us to perform our contractual obligations with NHS Trusts, authorised testing laboratories, authorised licensees. In some cases we may use your personal information to pursue legitimate interests, provided your interests and fundamental rights do not override those interests. The situations in which we will process your personal information are shown below.

• to conduct research and data analytics studies

• to contact you about future ethically approved research (subject to consent)

7. If you fail to provide personal information

If you fail to provide certain information when requested, we may not be able to perform our contractual obligations which may affect your care or we may be prevented from complying with our legal obligations.

8. Change of purpose

We will only use your personal information for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason and that reason is compatible with the original purpose. If we need to use your personal information for an unrelated purpose, we will notify you and we will explain the legal basis which allows us to do so.

Please note that we may process your personal information without your knowledge or consent, in compliance with the above rules, where this is required or permitted by law.

9. How we use particularly sensitive personal information

· "Special categories" of particularly sensitive personal information, such as information about your:

medical conditions; genotype DNA details; implant details (such as the type of implant and the date of your surgeries to help us determine the age of your implant); blood metal concentration reading levels; genetic information and biometric data, require higher levels of protection. We need to have further justification for collecting, storing and using this type of personal information. We have in place an appropriate policy document and safeguards which we are required by law to maintain when processing such data. We may process special categories of personal information in the following circumstances:

9.1 in limited circumstances, with your explicit written consent.

9.2 where we need to carry out our legal obligations or exercise rights in connection with MyOrthotypeTM.

9.3 where it is necessary to protect you or another person from harm.

Less commonly, we may process this type of information where it is needed in relation to legal claims or where it is needed to protect your interests (or someone else's interests) and you are not capable of giving your consent, or where you have already made the information public.

10. Situations in which we will use your sensitive personal information

In general, we will not process particularly sensitive personal information about you unless it is necessary for performing or exercising obligations or rights in connection with MyOrthotypeTM with your consent. On rare occasions, there may be other reasons for processing, such as it is in the public interest to do so. The situations in which we will process your particularly sensitive personal information are listed below. We have indicated the purpose or purposes for which we are processing or will process your more sensitive personal information.

We will use information about your physical health, or disability status, together information about your

implant (including the type of implant you had, why you had it implanted and subsequently then

removed) and to assess the impacts of your implant on you.

We will also use the findings of the information as part of improving our algorithm but also as part of essential post operation surveillance.

11. Do we need your consent?

We need your consent to allow us to process certain particularly sensitive data. If so, we will provide you with full details of the information that we would like and the reason we need it, so that you can carefully consider whether you wish to consent.

12. Data sharing

We may have to share your data with third parties, including third-party service providers.

We require third parties to respect the security of your data and to treat it in accordance with the law.

We may transfer your personal information outside the UK.

If we do, you can expect a similar degree of protection in respect of your personal information.

Why might you share my personal information with third parties?

We will share your personal information with third parties where required by law, where it is necessary to do so to meet our contractual obligations or where we have another legitimate interest in doing so.

Which third-party service providers process my personal information?

"Third parties" includes third-party service providers (including contractors and designated agents). The following activities are carried out by third-party service providers:

12.1 laboratory investigations (either within the national health service or a laboratory closely affiliated to the national health service).

These third parties will process a blood or saliva test which you gave at the time of consent to us.

12.2 Online cloud based server providers. These are third parties which we contract in relation to our IT systems. Online cloud based server providers allow your confidential personal data to be stored securely.

How secure is my information with third-party service providers and other entities in our group?

All our third-party service providers and other entities in the group are required to take appropriate security measures to protect your personal information in line with our policies. We do not allow our third-party service providers to use your personal data for their own purposes. We only permit them to process your personal data for specified purposes and in accordance with our instructions.

What about other third parties?

We may share your personal information with other third parties, for example in the context of the possible sale or restructuring of the business. In this situation we will, so far as possible, share anonymised data with the other parties before the transaction completes. Once the transaction is completed, we will share your personal data with the other parties if and to the extent required under the terms of the transaction.

We may also need to share your personal information with a regulator or to otherwise comply with the law. This may include MHRA, National Health Service and the National Joint Registry.

13. Transferring information outside the UK

We do not transfer information outside of the UK.

14. Data security

We have put in place appropriate security measures to prevent your personal information from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. In addition, we limit access to your personal information to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal information on our instructions and they are subject to a duty of confidentiality.

We have put in place procedures to deal with any suspected data security breach and will notify you and any applicable regulator of a suspected breach where we are legally required to do so.

15. Data retention

How long will you use my information for?

We will only retain your personal information for as long as necessary to fulfil the purposes we collected it for, including for the purposes of satisfying any legal, accounting, or reporting requirements.

For the data concerning your National Joint Registry access number (excluding any medical information) we retain this for the lifetime of the patient. The National Joint Registry will notify us of the removal of this number and we will action this appropriately.

For the data concerning your contact details (including your name, address and contact number) where you have consented to further ethically approved research we retain this for a maximum of 5 years.

To determine the appropriate retention period for personal data, we consider the amount, nature, and sensitivity of the personal data, the potential risk of harm from unauthorised use or disclosure of your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal requirements.

In some circumstances we may anonymise your personal information so that it can no longer be associated with you, in which case we may use such information without further notice to you.

Rights of access, correction, erasure, and restriction

Your duty to inform us of changes

It is important that the personal information we hold about you is accurate and current. Please keep us informed if your personal information changes during your working relationship with us.

Your rights in connection with personal information

Under certain circumstances, by law you have the right to:

· Request access to your personal information (commonly known as a "data subject access request"). This enables you to receive a copy of the personal information we hold about you and to check that we are lawfully processing it.

· Request correction of the personal information that we hold about you. This enables you to have any incomplete or inaccurate information we hold about you corrected.

· Request erasure of your personal information. This enables you to ask us to delete or remove personal information where there is no good reason for us continuing to process it. You also have the right to ask us to delete or remove your personal information where you have exercised your right to object to processing (see below).

· Object to processing of your personal information where we are relying on a legitimate interest (or those of a third party) and there is something about your particular situation which makes you want to object to processing on this ground. You also have the right to object where we are processing your personal information for direct marketing purposes.

· Request the restriction of processing of your personal information. This enables you to ask us to suspend the processing of personal information about you, for example if you want us to establish its accuracy or the reason for processing it.

· Request the transfer of your personal information to another party.

If you want to review, verify, correct or request erasure of your personal information, object to the processing of your personal data, or request that we transfer a copy of your personal information to another party, please contact the DPO in writing.

No fee usually required

You will not have to pay a fee to access your personal information (or to exercise any of the other rights). However, we may charge a reasonable fee if your request for access is clearly unfounded or excessive. Alternatively, we may refuse to comply with the request in such circumstances.

What we may need from you

We may need to request specific information from you to help us confirm your identity and ensure your right to access the information (or to exercise any of your other rights). This is another appropriate security measure to ensure that personal information is not disclosed to any person who has no right to receive it.

Right to withdraw consent

In the limited circumstances where you may have provided your consent to the collection, processing and transfer of your personal information for a specific purpose, you have the right to withdraw your consent for that specific processing at any time. To withdraw your consent, please contact the DPO. Once we have received notification that you have withdrawn your consent, we will no longer process your information for the purpose or purposes you originally agreed to, unless we have another legitimate basis for doing so in law.

Data protection officer

We have appointed a data protection officer (DPO) to oversee compliance with this privacy notice. If you have any questions about this privacy notice or how we handle your personal information, please contact the DPO on the contact details listed below :

Our full details are:

Full name of legal entity: PXD Limited

Name or title of DPO: David Langton

Email address: davidl@explantlab.com

Postal address: The Biosphere Draymans Way, Newcastle Helix, Newcastle Upon Tyne, England, NE4 5BX

Under certain circumstances, you have rights under data protection laws in relation to your personal data including the right to receive a copy of the personal data we hold about you and the right to make a complaint at any time to the Information Commissioner's Office (ICO), the UK regulator for data protection issues (www.ico.org.uk). You also have the right to make a complaint at any time to the ICO with respect to data protection issues.

Changes to this privacy notice

We reserve the right to update this privacy notice at any time, and we will provide you with a new privacy notice when we make any substantial updates. We may also notify you in other ways from time to time about the processing of your personal information.