The FDA recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes, which requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology including hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data.
It has issued a guidance document explaining that it does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.
