Analysis of Legal and Regulatory Frameworks in Digital Health: A Comparison of Guidelines and Approaches in the European Union and United States

The advent of digital technology in healthcare presents opportunities for the improvement of healthcare systems around the world and the move towards value-based treatment. However, this move must be accompanied by strong legal and regulatory frameworks that will not only facilitate but encourage the good use of technology. The goal of the study was to assess the amenability and furtherance of regulatory frameworks in digital health by evaluating and comparing the processes, effectiveness and outcomes of these frameworks in the European Union and United States. Methods: This study incorporated two research methodologies. The first was a research of current legal and regulatory frameworks in digital health in the European Union and United States. A comprehensive online search for publications was carried out which included laws, regulations, policies, green papers, guidelines and recommendations. This research was complemented with interviews of five purposively sampled key informants in the legal and regulatory landscape. Results: Mind-maps revealed key features and challenges of the digital health field in the topics of the current state of regulation of digital health in the EU, Germany and US, regulatory pathways for digital health devices, protection and privacy of health data, mobile health validation, risk-based classification of medical devices, regulation of clinical decision support systems, telemedicine, artificial intelligence and emerging technologies, reimbursement for digital health services and liability for digital health products. The experts expressed and explained key points where current regulation is deficient. The review of the legal frameworks revealed deficiencies which provide opportunities and recommendations to further develop and strengthen the regulatory landscape. Conclusions: A key element to a robust regulatory framework is the ability to ensure trust and confidence in using digital health technology. Technology must measure the impact on quality of life and burden of disease and not merely involve the collection of data