Draft For Clinical Studies of Digital Health Technologies


Draft guidance for all the investigators, sponsors has been issued by the FDA- Food and Drug Administration when it comes to using digital health technologies as a tool to gather data remotely from all the participants across various clinical investigations. DHT comprises computing platforms, sensors, and connectivity, for all the healthcare and interconnected uses.

Cardiovascular Patients’ Tryst With Technology

The simplest and easy-to-understand form would be a smartwatch with sensors that collects vital information on heart rate. The DHT’s accentuate data transmission across the length and breadth, which thereby increases patient participation in trials and therefore, collects their data consistently and frequently. The draft details some key points to consider for people, especially the sponsors using DHT’s during clinical investigations.

Healthcare, being in the eye of the storm, keeps transforming. In order to better understand human health, the research needs to be consistent as far as funding is concerned and at the same time find alternatives to not only treat illness, injuries, etc., but also prevent it. The fact is that with every singular development in technology, healthcare tech development takes place too. Since healthcare had to evolve with time, especially during the pandemic, innovations had to be at their peak in the case of at-home heart healthcare. The cardiovascular disease jump has left us with no choice but to adopt the digital health platforms which assist in managing at-home care with precision and absoluteness. An as simple as a decent heart monitor which is as handy as it can get, as well as a workout schedule can help patients track what their body is up to. All thanks to innovation, heart monitors have moved from being big, rusty, and cold devices to more stylish, power-packed, and small gadgets which do more than what they are expected to be doing.

Clinical Research And Wearables

Digital Health Technologies has more to it than meets the eye. Like the wearables and sensors are an integral part of DHTs, they have also started to play a crucial role in clinical research, which is due to decentralized clinical trials as well as remote patient monitoring.

Choosing The Best DHT

Fit for purpose should be the approach to look for when opting for a DHT, particularly in clinical investigation. The level of validation must be enough to ensure support of a DHT’s use and its interpretability. The FDA recommends the following points to be taken into account by the sponsors for that perfect DHT.

  • The attribute of the disease or the condition be measured.
  • Clinical investigation design
  • DHT attributes that may influence the trial participant

Verification And Validation Holds The Key

The studies about validation and verification should showcase that the attribute which needs to be assessed is consistent and measured accurately in the given universe. For instance, DHT that might capture the steps of a healthy participant may not be used in the case of people suffering from Parkinson’s disease.

The sponsors thereby must look into DHTs specification on performance, its reliability when it comes to functions and also make sure that all the brands from the DHT gamut put in similar data. Usability studies must analyze the use of DHT in the population they intend to be used in and also assess the factors that affect the to-the-point accuracy of the instrument.

Potential Risks To Fight Out

The draft also suggests that the potential risk of disclosure of information should be considered either through a DHT breach or the licensing agreement of the end-user.

Apart from all the above-mentioned points, the guidance also looks into considerations and edits of instances of how different DHTs can be used for the investigations. Before going ahead with the study, the sponsors using the DHT technology must look into contacting the FDA center, which is responsible for the medical product.