Data Protection Compliance in Healthcare
The promotion of health and wellbeing and the development of the therapies that people need depend intensively on the processing of personal data. Indeed, health data form the basis for research into new treatments and the development of therapies and medical devices. However, the processing of precisely this data is subject to special and more stringent data protection law requirements due to its sensitivity. Companies in the healthcare field must therefore implement creative solutions to access the data that they need while ensuring the protection of the rights of the data subjects and of their own reputation and business.
Therefore, it is of utmost importance for them to find a data protection partner that understands that more data means better health and works with them to creatively overcome the legal obstacles that they face thus supporting them in their quest to ensure medical progress.
FIRST PRIVACY Health & Medical is at your side with many years of experience in data protection in the healthcare sector and our unwavering commitment to the development of medicine.
Finding creative solutions to comply with data protection obligations is essential to unlock innovation in healthcare. FIRST PRIVACY will support your business through individualized consultancy aimed particulary at,
- Creating a tailor-made data protection compliance strategy to support the development of breakthrough medicinal products and devices.
- Implementing an adequate compliance strategy to identify potential risks to patient privacy, for the success of clinical trials, and to protect the companies’ reputation while advancing science.
- Providing multi-jurisdictional legal consultancy and support in order to develop products that are privacy compliant by design and by default.
Worldwide data protection laws consider health data as belonging to the special categories of data also known as “sensitive data”. Therefore, companies and organizations have to meet very stringent requirements to process personal data concerning the past, current or future physical or mental health status of the data subject.
The unlawful processing of health data could lead to high fines and severe reputational damages.
Cross border transfers of healthdata shall also be regulated according to the law of the sending and receiving countries and frameworks. Thus, internationally operating companies must not only consider their local or regional data protection regulations but also international laws.
FIRST PRIVACY Health & medical monitors the international data protection compliance environment for you and helps you meet all applicable requirements to allow you to concentrate your efforts in maintaining a thriving business developing the health products and technologies that people need.
- Providing legal support for the designing of compliant-by-design medicinal products and devices;
- Supporting with approval processes before data protection authorities;
- Providing legal support for the designing of compliant-by-design data processing for AI model training;
- Development of a data protection compliance strategy suited to your product's specific regulatory requirements;
- Counseling for the implementation of multi-site clinical trials compliant with applicable local, regional and international data protection regulations;
- Offering online or on-site extensive trainings on data protection-related topics relevant to the industry;
- Worldwide support with clinical trials, transparency obligations and pharmacovigilance;
- External Data Protection Officer and Data Protection Representative Services.
- How can we draft and submit a compliant informed consent form (ICF), in particular when different legislations shall be observed?
- How can we develop a clinical trial design to be compliant worldwide?
- How can we implement a multi-site clinical trial that complies with the data protection regulations of different jurisdictions?
- How can we address the requirements and feedback from the applicable ethics committees?
- How can we choose a privacy-compliant vendor for our processes involving medical data?
- How can we ensure that our patient database is secure and compliant?
- How can we ensure that our contracts with service providers processing health data on our behalf are data protection-compliant?
- How can we make sure that the medical device that we're developing is compliant-by-default?
- How can we comply with our transparency obligations across different jurisdictions and in different languages?
FIRST PRIVACY provides data protection consulting services to four of the world’s top twenty pharmaceutical companies. FIRST PRIVACY has a specialized Health & Medical team, who will support you whether in the middle of your journey or throughout your whole product development process.
- Experienced consultants specialized in International Data Protection Compliance.
- One-stop shop offering services in different jurisdictions and in 8 of the EU official languages.
- FIRST PRIVACY Health & Medical can effectively address the specific needs of healthcare, pharma and medical tech companies offering tailor-made data protection-compliant solutions and strategies.
We will harness our vast know-how in the Pharma and Med Tech sector to guide you every step of the way, ensuring that you are well-equipped to navigate international and multi-jurisdictional regulatory challenges.
We will apply our solution-oriented approach to develop bespoke data protection strategies to make your products data protection compliant by design and by default.
Our unwavering commitment to driving scientific development is fueled by the belief that more data means better health and we pledge to be your steadfast partner in realizing your mission.
Dr. Nora Alim, LL.M.
Phone: +49 421 69 66 32-826
Marina Anagnostaki, LL.M.
Phone: +49 421 69 66 32-827
Dr. jur. Verónica Miño
Partner (ppa) | Senior Privacy Counsel
Phone: +49 421 69 66 32-887
Juan Carlos Vargas Carrillo, LL.M.
Phone: +49 421 69 66 32-828
By considering your data processing operation as a whole, a data protection compliance strategy provides your company with a step-by-step guide of the requirements, timelines and procedures applicable to your particular journey. Unlike a reactive approach that consumes vast resources in a disorganized way, a data protection compliance strategy proactively assesses the applicable requirements and decides on timely, organized and time-efficient ways of meeting them.
If your company processes health data across two or more jurisdictions, you would benefit from a data protection strategy to guide you through the different national requirements, applicable laws, authorities and procedures. A data protection compliance strategy allows you to timely and efficiently consider all the requirements applicable to your data processing operation in order to proactively plan the steps to be followed for the successful and cost-efficient launching of your product.
Processing health data for health-care purposes would per se make a data protection compliance strategy desirable. If you add that to the fact that medical research and the development of health-related medicines and devices, require also the transnational processing of personal data, it becomes clear that a data protection compliance strategy is not only desirable but required. Considering that different laws apply to the processing of personal data in different countries, that transparency obligations vary across jurisdictions and that service providers and health-care institutions from different countries, as well as different authorities and committees, shall be coordinated, a data protection compliance strategy is instrumental for the successful launching of your product.
Health data belongs to the special categories of data. Companies and organizations shall meet strict regulatory requirements to compliantly process this category of personal data and to transfer it to other countries where business partners, investigators or service providers may require to process it. Knowing, understanding, keeping in mind and complying with all the applicable regulatory requirements can be time and money consuming and can lead to your company’s inability to comply with the law and/or to its inability to process the data that you require to develop and ultimately launch your product. Fortunately, FIRST PRIVACY Health & Medical can help you meet your regulatory requirements while maintaining a thriving business developing the health products and technologies that people need.
A medical device developed integrating appropriate and sufficient safeguards into the processing of personal data in order to protect the rights of data subjects and meet the requirements of the applicable laws is compliant-by-default. In order to develop a compliant-by-default device, all the data protection-relevant circumstances of the product’s development journey shall be assessed. A proactive approach allows you to take care of data protection compliance while developing the product rather than making expensive and time-consuming changes once the product is ready to be launched.
Four of the top twenty pharmaceutical companies have chosen FIRST PRIVACY as their partner for data protection compliance. Not only do we have a team of experts in your field who can advise you on the best and most efficient way to comply with data protection requirements across all the jurisdictions applicable to your project but we can communicate with you, the applicable authorities and the concerned data subjects in 8 of the official languages of the European Union. We believe that more data means better health and are eager to facilitate your project’s compliance with the applicable data protection laws while you concentrate on your business and develop more and better medicines and medical devices.