Regulation of Clinical Decision Support Software – 21st Century Cures Act Changes FDA’s Regulatory Game

Regulation of Clinical Decision Support Software is much clearer now, thanks to the 21st Century Cures Act.

Section 3060, entitled Clarifying Medical Software Regulation, amends Section 520 of the federal Food, Drug, & Cosmetic Act (FDCA) by adding language about Regulation of Medical and Certain Decisions Support Software.

The new language states that a medical device shall not include a software function that is intended:

  1. for administrative or operational support of a healthcare facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics … [and other purposes];
  2. for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
  3. to serve as electronic patient records, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as such records were created, stored, transferred, or reviewed by health care professionals (and other conditions, including that the records are not intended to interpret or analyze patient records … for the purposes of diagnosis, cure, mitigation, prevention, or treatment of a disease);
  4. for transferring, storing, converting formats, or displaying clinical laboratory or other device data and results, findings by a health care professional with respect to such data and results ….
  5. Unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device

Notwithstanding the above, a software function that meets any of the above criteria can still be considered a medical device if the Secretary of Health & Human Services makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences, and identifies this in a final order, pursuant to the rules around such. In making a finding with respect to a software function, the Secretary must take into account, among other things, the likelihood and severity of patient harm if the software were not to perform as intended, and the extent to which the software function is intended to support the clinical judgment of a health care professional.

Further, the Secretary may exercise enforcement discretion as to any device.

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