Abstract
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.
Highlights
Digital technology in healthcare presents many opportunities for the improvement of healthcare systems around the world
Though medical devices are bound to the rules of the Medical Device Regulation (MDR), Mobile health (mHealth) applications seldom undergo the critical evaluation of the MDR as compared to conventional medical devices.[2]
Frameworks applied to medical devices as compared to those applied to other forms of digital health have different requirements
Summary
Digital technology in healthcare presents many opportunities for the improvement of healthcare systems around the world It is one of the most significant tools that will enhance the move towards value-based treatment. FDA guidance document detailing the premarket submission of off-the-shelf software; details needs and responsibilities of the manufacturer FDA guidance document detailing the identification of medical device data systems, medical image storage devices and medical image communication devices that the FDA will not enforce regulatory controls FDA guidance document detailing the regulatory oversight of CDSS intended for healthcare professionals and patient decision support software intended for patients, care givers FDA guidance document mapping FDA’s oversight approach to software and mobile medical applications US report showing state-wise telehealth services and reimbursement policies. Title and Year Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within current authorities (2019)[29] Proposed Regulatory Framework for Modifications to Artificial Intelligence / Machine learning - Based Software as a Medical Device (SaMD) (2019)[30] Off-The-Shelf Software Use in Medical Devices (2019)[31] Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (2019)[32] Clinical and Patient Decision Support Software (2019)[33]
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