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.
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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.
The FDA is establishing its Digital Health Program in order to fulfill its mandate of protecting public health while maintaining regulatory clarity by increasing outreach to consumers and establishing regulatory policies that reflect the new digital health technologies. As part of that program, the FDA is expected to formally adopt, in some fashion, the International Medical Device Regulators Forum’s guidance offered in its report: “Software as a Medical Device: Clinical Evaluation”. Another step in this process is to remove certain items from regulation. For example, electronic health records and programs that merely encourage healthy habits or display or store data are excluded from the definition of a medical device. This not only reduces the items subject to FDA regulation but also provides needed clarification for designers, producers and marketers of this technology.
A pre-certification pilot program for makers of stand alone device software is another aspect of the FDA’s attempt to encourage digital health developers. The program will allow the FDA to establish criteria to determine if a developer can produce quality, safe and effective software, and once the criteria are established, qualifying developers would be precertified to receive a simplified premarket review. Some developers of some products could conceivably be freed of any requirement for premarket review. This program would only be available for the development of very low risk products. Additionally, the developer would be responsible for collecting data to ensure that the product is effective and safe once it is on the market.
Finally, the FDA is expected in the relatively near future to provide additional information in several areas. One such area is the currently murky question of when a developer must submit for review any changes to a currently approved device or software. Another area needing clarification is which clinical decision support software will still be subject to regulation and which will become exempt.
Regardless of how one views current government regulation, as these many changes are put into practice, the legal questions regarding what is regulated and to what extent under the new system will take some time to work out, no matter how much effort the FDA puts into answering these question up front. Additionally, users and prescribers of these products need to be aware that it appears that there will be significantly less oversight of some products resulting in the need for more individual responsibility in choosing among available options.
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** Disclaimer: Thoughts shared here do not constitute legal advice. Please consult with an attorney to discuss your legal issue.
“Digital Health,” U.S. Food and Drug Administration (June 9, 2017); “FDA Makes Moves to Advance Digital Health,” Kim Tyrell-Knott, Epstein, Becker and Green.