In late 2016, the 21st Century Cures Act was passed to assist the FDA in keeping pace with the rapid changes in health care technology. Our business and healthcare law firm, follows developments in the healthcare industry.
Among other things, this Act amended the definition of a “device” in the Food, Drug, and Cosmetic Act to remove some medical software functions. The immediate result is that the FDA must draft new guidance for its oversight of software for medical devices.
Healthcare Technology Lawyers
Included in the concept of “Digital Health” are health information technology, wearable devices, personalized medicine, mobile health and telemedicine. The FDA has recognized that these technologies are used to reduce cost and inefficiencies, improve care and access, and better tailor medicine to the individual patient. Furthermore, patients can use the technology on their own to track and manage their own health activities. The FDA acknowledged that new technology allows unprecedented opportunities for people to obtain and potentially share information that can result in significant improvements in health care.