Privacy Notice – Study Participants

Definition

Type of personal data

Identity Details

• Name
• Address
• Telephone/Email

This data will be used in limited circumstances where you contact us directly, or you suffer a Study-related injury, or where we need to obtain the data from the Study Site in order to contact you in an emergency.

Study Data

• Your assigned patient code/reference number
• Your date of birth
• Photographic image(s) of your wound(s)
• Label(s) associated with the photographic image(s) (such as but not limited to your assigned patient code/reference number, hospital and visit number and date of visit)
• Wound assessment information (e.g., type and dimensions of the wound, tissue composition, wound location, treatments/products applied, underlying medical conditions and interview data)
• Relevant medical history (including causes of injury, height, weight, age, date of birth, country of residence, gender, ethnicity, prior medical treatments and procedures and pre-existing medical conditions/comorbidities)
• Information about your health and wellbeing, collected as part of the physical examination and treatment and explained in the Patient/Subject Information Sheet and the Informed Consent Form. This includes your general health during the course of the Study, data gathered as part of our monitoring of your health during the Study, therapy applied, home visit diary/report completed by the home care nurse, your compliance with treatment, the pain you are experiencing and your response to treatment under the Study, any side-effects experienced by you and questionnaires completed by you about your overall quality of life
• Your Study Site appointments, homecare visits, number of visit and dates of visits

What we do and why:

• We will review your medical history information in order to assess if the Study is suitable for you and to consider the continuous suitability of this Study for you and to determine whether any adjustments are necessary to facilitate your participation.
• If the Study is suitable for you and throughout your participation in the Study, we collect and analyse your Study Data to create medical reports on the use and benefits of our products and treatment and to perform research to develop, improve or assess our products. We need to process your Study Data to draw conclusions from the result of the Study. 

Our legal basis for processing:

We have a legitimate interest to process your Study Data for the purpose of performing the Study, and to be able to conduct our scientific and medical research within the scope of the Study. We consider that the wider public interest in advancing wound care and healing through medical research means that we can lawfully process your personal data for these purposes.

What we do and why:

• We process your Study Data in order to administer the Study and your participation in the Study, including collecting your informed consent to participate in the Study in accordance with good clinical practice, and to execute our insurance policies.
• We may process your Identity Details in order to deal with any questions or complaints you may make to us, and to respond to and deal with an exercise of your data protection rights (although we advise you in first hand to reach out to the Study staff for this purpose, as this will better protect your privacy as explained under the section “Your Rights”).
• We may process your Identity Details and Study Data for the purpose of supporting the transfer or merging of part or all of our business or assets, or in connection with the acquisition of another business.

Our legal basis for processing:

We have a legitimate interest to process your personal data in order to administer and coordinate the Study and your participation in the Study, as well as to conduct business operations that are related to the Study. We consider that the wider public interest in advancing wound care and healing through medical research means that we can lawfully process your personal data for these purposes.

What we do and why:

• We process your Study Data to ensure the safety and reliability of the Study as well as to ensure compliance with our policies governing our research procedures, including safety reporting, archiving  and disclosure of Study Data to national competent authorities in the course of an inspection.
• We process personal data where it is in the vital interests of you or someone else (i.e. to protect your life), for example where we need to contact the appropriate person in the event of an emergency involving you or someone else.

Our legal basis for processing:

We have a legal obligation to process your personal data to ensure the safety and reliability of the Study in compliance with the rules regulating the conduct of clinical investigations (such as the EU Medical Device Regulation or the US Food, Drug and Cosmetic Act). We may also be required to process your personal data where this is necessary to protect your life (or someone’s else’s life). 

What we do and why:

We process your Study Data when using it in training materials and textbooks, as well as in live training sessions and recorded educational videos published or delivered by or on behalf of us, which are aimed at educating healthcare practitioners in wound care.

Our legal basis for processing:

We will only process your Study Data for this Secondary Purpose if you have given your explicit consent to the processing. You have the right to withdraw your consent at any time. A withdrawal of your consent will mean that your Study Data will stop being used for this specific purpose.

What we do and why:

We process your Study Data for the purpose of product development (including development in areas of artificial intelligence and machine learning). Your Study Data will be used to assist Mölnlycke in developing digital products and solutions (e.g., SaMD (Software as a Medical Device) and AIaMD (AI as a Medical Device)), aimed at improving quality of care and outcomes for patients by supporting diagnostics and monitoring, the treatment and management of wounds and the prevention of infection and disease.

The technology used for product development may include elements of so-called profiling. Profiling means the processing of your personal data to analyse aspects of your physical traits. Mölnlycke does not use profiling to make any decision that would affect you in any way.

Our legal basis for processing:

We will only process your Study Data for this Secondary Purpose if you have given your explicit consent to the processing. You have the right to withdraw your consent at any time. A withdrawal of your consent will mean that your Study Data will stop being used for this specific purpose.

What we do and why:

Your Study Data may be used in our advertising, scientific publications or promotional/marketing activities in relation to Mölnlycke’s products and Mölnlycke research and clinical study activities. These activities will be aimed at the medical sector, including hospitals, clinics and health care practitioners. Any pseudonymised wound label will be removed or redacted from all photographic images used for these purposes.

Our legal basis for processing:

We will only process your Study Data for this Secondary Purpose if you have given your explicit consent to the processing. You have the right to withdraw your consent at any time. A withdrawal of your consent will mean that your Study Data will stop being used for this specific purpose.