Digital Health Regulation begins in England
The National Institute for Health and Care Excellence (NICE) has just released new standards that set requirements for the development of digital health technologies for the National Health Service (NHS).
The purpose of these standards is to establish guidelines for developers and investors who intend to introduce digital health products into the NHS. The delimitation of a regulatory framework should accelerate the capture of products such as health apps and wearable devices in the healthcare system.
The trend is that measures such as this will be adopted in the coming years in different countries, including Brazil.
Digital technologies have played increasingly important roles in everyday life and are also starting to be used as important tools for diagnosis, prevention, monitoring and health treatment. This will radically change the way health care is planned, provided and received. It is therefore imperative that appropriate regulation is in place to ensure quality and safety for users and also legal certainty for innovative digital healthcare companies.
As these new technologies are emerging at a fast pace, the existence of clear parameters on the evidence needed for product approval in health systems is essential. It is in this sense that NHS begins to define a normative framework that supports the development of digital health technologies while ensuring quality and safety standards for users. The new standards address both the clinical and economic impact and also identify the level of evidence required for products to be entered into the NHS. This should enable the health system to identify which products are promising, those that need further development, and indicate those that are not appropriate.
Daniel A. Dourado