The FDA is updating its position and regulatory control of decision-support software. Since 1989, the use of computer-based products and software-based products as medical devices has grown considerably and the FDA is now rethinking its position on computer-generated information resulting from primary patient data. How the data is collected, input into a computer, interpreted, analyzed and used has sparked much debate within the regulatory confines of the FDA. The FDA will report new guidance for use of clinical decision support software sometime during 2012.
The FDA is entering into uncharted waters and seeks to broaden its influence on how information is used to calculate, predict and recommend clinical actions.
Some of the issues facing the FDA and software developers include:
- EHRs that do more than simply passively store medical information for later retrieval. If algorithms or other calculations are used to produce new information, we can expect they will be considered for regulation.
- Consumer-targeted software that facilitates diagnosis or makes treatment recommendations based on manually entered data.
- Supercomputers that crunch large volumes of data in an effort to improve patient diagnosis or care planning. An example might be software that analyzes physician notes stored in a patient’s EHR for trends in observations or symptoms over time in order to diagnose a medical condition (e.g., seasonal allergies).
- Software that makes treatment recommendations for whole groups of patients, where the intent is to act upon the recommendation, as opposed to simply learning something. Calculations that suggest action be taken are likely candidates for regulation.
- Software that performs other advanced analytics that have a direct impact on patient safety. Examples include software that evaluates a patient’s fall risk potential and recommends precautionary interventions.
- Software that monitors patients current status or that manages patient work-flow, if such software significantly impacts patient safety. For example, this would include software that prioritizes specific patient-nursing care demands over other patients for clinician review due to anticipated severity of the individual’s condition.
Regulation of software will surely limit language and marketing claims of effectiveness. The following list of terms will certainly draw FDA attention:
- “Decision support,” “artificial intelligence,” “learning systems;”
- “Real-time” or “active” (suggesting no time for the exercise of professional judgment of a healthcare professional);
- “Patient-specific,” “personalized,” “patient centric”(suggesting that the software somehow produces individualized actionable information);
- “Integrated” (suggesting that a regulated medical device can easily transfer information into the software); and
- “Flags,” “notifications,” or “alarms” (suggesting there is a real-time alert that should be acted on by a healthcare professional).
FDA’s regulatory approach for CDS appears destined to change significantly in 2012. If the future of this software category is important to you, you’ll want to monitor it closely and get engaged