Patient & Care Giver Privacy Notice

Version: 3

Effective Date: 05 May 2022

Last Reviewed: April 2022

Introduction

This privacy notice is provided by MDE Services Group Limited and its affiliated companies (collectively “We”). We specialise in solutions which support the effective delivery of clinical trials. Services include personalised patient and caregiver support, mobile health and decentralised trial visits, site analysis and management, travel and logistics, expense reimbursement and clinical trial meetings management. We also specialise in the recruitment of agency healthcare and research professionals into patient health services and clinical trials.

The organisation facilitating the study for the patient, otherwise called the study sponsor, is the data controller and is primarily responsible for the personal data collected during the study. We are facilitating certain services on behalf of the study sponsor or CRO which makes us a data processor or sub-processor in respect of your personal data. This notice describes how we as a data processor or sub-processor, collect, use, and manage the Personal Data we hold about you, including how the Personal Data may be shared and how the confidentiality of Personal Data is maintained.

We share and process your Personal Data with certain third parties as described in the “Data Sharing and Transfers” section below. Full details of our Affiliates can be found at section 1.13.

The “At a Glance” section contains some very important information that will help explain what Personal Data we process and why. Capitalised terms used in this notice are defined in Personal Data Types (section 1.12) and Affiliates (section 1.13).

At A Glance

1.1 When do we collect Personal Data?

When we refer to Personal Data in this notice, we mean information that can or has the potential to identify someone as an individual.

We will collect and process Personal Data about an individual at the following stages:

1.2 What Personal Data may we collect from you and why?

Patient Engagement:

During this stage we rely on your ‘Consent’ to process an individual’s Personal Data.

Service Delivery:

During this stage we will largely rely on ‘Contractual Necessity’ to process your Personal Data apart from Personal Data marked with a (#) below where we will rely on ’Compliance with a Legal Obligation’.

For further details of the Personal Data types contained within each category please refer to the Personal Data Types which can be found in section 1.12.

Any decision to provide any Personal Data described above to us is voluntary. If individual’s chose not to provide any of the Personal Data requested or does not consent, we may not be able to provide them with our services and we may be prevented from complying with our legal obligations.

Further Detailed Information

1.3 Data Sharing And Transfers

In the usual course of business, we may disclose Personal Data which will include health information as recorded below (to the extent necessary) to (i) our Affiliates, and (ii) certain third-party processors we have retained to perform services on our behalf and pursuant to our instructions. This may include sharing with:

• Affiliates for the provision and delivery of services, IT application support, internal audits and investigations, quality control, program monitoring, management reporting and other internal purposes.
• Affiliates to deal with any legal and compliance matters, providing assessment results, for record keeping, internal audit, reviews, management information, operational, administrative purposes.
• Medical sites when seeking approval in relation to your reimbursement claim or to confirm when travel is arranged, and accommodation requirements are met.
• Auditors, lawyers, accountants, consultants, and other professional advisors.
• Business partners, suppliers, and sub-contractors for the provision of the contracted services such as travel companies and airlines.
• Organisations providing IT systems support and hosting in relation to the IT systems on which your Personal Data is stored.
• Third parties in connection with a disposal of assets, restructuring, merger or sale activities.

Where a third-party data processor is used, we ensure that they operate under contractual restrictions regarding confidentiality and security, in addition to their obligations under data protection laws.

We may also disclose your Personal Data (iii) if we are required to do so by law or legal process, or (iv) in response to lawful requests from public authorities, including to meet national security, public interest, or law enforcement requirements. We also reserve the right to transfer Personal Data in the event of an audit or if we or any of our Affiliates sell or transfer all or a portion of their business or assets (including in the event of a merger, acquisition, joint venture, reorganization, dissolution, or liquidation).

1.4 Third country data transfers

Due to the global nature of our operations, we may transfer the Personal Data we collect about you to recipients in countries other than the country in which your Personal Data originally was collected. For example, we may disclose Personal Data to our Affiliates based in the U.S. or other offices worldwide.

Where we transfer the Personal Data to a country which may not have the same data protection laws as the country in which they were initially provided (such as the U.S.), each such party will protect that Personal Data as described in this Privacy Notice and will comply with applicable local legal requirements providing adequate protection for the transfer of Personal Data to recipients in countries other than the one in which you provided the Personal Data.

Where Personal Data is transferred to a country that does not have adequacy, we have implemented appropriate safeguards to ensure an adequate level of data protection, including by concluding data transfer agreements incorporating the European Commission’s Standard Contractual Clauses under Article 46 of the GDPR. You may contact the Privacy Office as indicated below to obtain further information on the transfer mechanism.

1.5 Health information collected during the provision of services

Special category data (including information relating to your health) will only be disclosed to third parties in accordance with this Privacy Notice. That includes third parties involved with your treatment or care, or in accordance with applicable laws and guidelines of appropriate professional bodies.

Where applicable, it may be disclosed to any person or organisation who may be responsible for providing treatment and or care. It may also be provided to external service providers and regulatory bodies for the purpose of clinical audit to ensure the highest standards of care and record keeping are maintained.

Medical professionals involved in the provision of our services: We may share clinical information about you as a patient with medical professionals as we think necessary for the delivery of service and care.

Sites: We may liaise with the medical center (i.e., hospital or doctor’s office) regarding your participation in a clinical trial.

1.6 How we protect Personal Data

We maintain appropriate technical and organisational measures designed to protect Personal Data against loss or accidental, unlawful, or unauthorised, alteration, access, disclosure, or use.

1.7 Retention period

We retain Personal Data for as long as we reasonably require it for legal and business purposes. In determining data retention periods, we also take into consideration local laws, relevant regulations, and the contractual obligations or instructions that are specifically given by the study sponsor.

1.8 Data subject rights

At any point while we are in possession of or processing Personal Data, you have the following rights:

• Right of access – the right to request a copy of the Personal Data that we hold about you. We reserve the right to charge a reasonable fee based on our administration costs where further copies are requested.
• Right of rectification – the right to correct Personal Data that we hold that is inaccurate or incomplete.
• Right to be forgotten – in certain circumstances you can request the Personal Data we hold about you to be erased from our records.
• Right to restriction of processing – where certain conditions apply you have the right to request that we restrict the processing.
• Right of portability – in certain circumstances you have the right to have the Personal Data we hold about you transferred to another organisation.
• Right to object – you have the right to object to certain types of processing such as direct marketing.
• Right to object to automated processing and profiling – you have the right to object to automated processing and profiling.

All the above requests will be forwarded on should there be a third party involved in the processing of the Personal Data.

If you would like to exercise any of your data subject rights, please contact us using one of the methods highlighted below.

1.9 Cookies

We may use cookies to distinguish the user from other users of our Website, App, App Site or App store. This helps us to provide a good experience when individuals browse our website, use the Apps, and also allows us to improve our services.

1.10 Contact Information

Any questions about this notice or the processing of Personal Data by us or any of our Affiliates, should be directed to the Privacy Office:

• By email at privacy@mdgroup.com or
• By writing to us at Privacy Office, mdgroup, Building 329, Doncastle Road, Bracknell, Berkshire, RG12 8PE United Kingdom

1.11 Complaints

If you wish to make a complaint about how your Personal Data is being processed by us (or third parties as described in 1.3 & 1.4 above) you should contact the Privacy Office at either of the address detailed above.

If you are not satisfied with how your complaint has been handled, you have the right to lodge a complaint directly with the relevant supervisory authority.

The UK regulator can be contacted at the Information Commissioners Office (ICO) Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF Tel 0303 123 1113

Our designated EU regulator is the Irish Data Protection Commission (DPC) who can be contacted at 21 Fitzwilliam Square, South Dublin 2, D02 RD28 Tel 017650100 / 1800437737

1.12 Personal Data types & items which may be processed

1.13 Affiliate

In relation to MDE Services Group Limited or any Affiliate, any subsidiary or holding company of that entity and any subsidiary or holding company of that entity.

1.14 Lawful Basis of Processing

Under the General Data Protection Regulation (GDPR), the lawful bases we rely on for processing this information are.

1.14.1 Consent

In certain circumstances, we are required to obtain your consent for the processing of the Personal Data in relation to certain activities.

Article 4 of the GDPR states that (opt-in) consent is “any freely given, specific, informed and unambiguous indication of the data subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of Personal Data relating to him or her.” In plain language, this means that you:

• have to give us consent freely;
• have to know what they are consenting to;
• should have choice over which processing activities you consent to and which you don’t; and
• need to take positive and affirmative action in giving us your consent;

We will keep records of the consents that we have received.

Where consent has been provided you have the right to withdraw it. This can be exercised at any time by contacting our privacy office recorded in section 1.10 above.

1.14.2 Contractual Necessity

Article 6 of the GDPR states that we can process Personal Data on the basis that such processing is necessary to enter or perform a contract.

The ’Contractual Necessity’ lawful basis permits the processing of Personal Data in two different scenarios:

• Situations in which processing is necessary for the performance of a contract to which you are a party. This may include, for example, processing your financial details for the processing of reimbursement claims.
• Situations that take place prior to entering a contract such as pre-contractual relations.

1.14.3 Compliance with a Legal Obligation

Article 6 of the GDPR states that we can process Personal Data on the basis that we have a legal obligation to perform such processing. Processing is permitted if it is necessary for compliance with a legal obligation.