Study on Health Data, Digital Health, and Artificial Intelligence in Healthcare
The European Commission has published a study on health data, digital health and artificial intelligence in healthcare. The study is aimed at providing information that will allow the European Commission to make informed policies in the areas of: digital health products and services, artificial intelligence in health, governing the use of health data and evaluating Article 14 of Directive 2011/24/EU. Directive 2011/24/EU established the rights that EU citizens have to healthcare in any EU countries, and the right to be reimbursed for healthcare in their home country. As a result of the study, there have been five main needs established:
- Establishing labeling/certification/authorization guidance for digital health service and products
- Defining the scope of telehealth/mHealth products and services to be reimbursed
- Facilitating the use of digital products/services to be reimbursed
- Ensuring transparency of digital health services and products provided cross-borders
- Ensuring an appropriate liability framing for digital health
The study also found that a common framework at an EU level is required to facilitate
access of health data for research, policy making and regulatory decisions. Additionally, the study finds that while the eHealth network was effective following the COVID-19 pandemic, previous initiatives had some efficiency issues when not supported by a regulation. There are several recommendations made regarding Article 14 of Directive 2011/24/EU. These recommendations include revising Article 4.2 (f) and Article 5 (d) to strengthen digital access to data, creating ad-hoc regulation to support the network initiatives and potentially making the MyHealth@EU platform available to patients to increase access to personal health data in a cross-border environment.
