The Food and Drug Administration has proposed new rules on how health tech products should be regulated—or not. In a new report, the agency outlines three new categories, from high to low risk, based on potential risk to patient safety rather than on the tech platform used, as in previous practice.
The high-risk category includes medical device systems, such as bedside monitor alarms, and will continue to be regulated by the FDA. Administrative health IT products, such as billing and claims software, and inventory management systems, are termed low risk, and will not be regulated.
The recognition of an additional low risk category is the big news. It includes medication management, clinical-decision support software, and other health management IT products. This area is rapidly changing, and the decision by the FDA to not regulate it with detailed rules helps developers and manufacturers to speed up the innovation process to bring new health tech products to market.
Bottom line, the proposed framework protects patient safety, but allows free rein for the production of new apps for mobile devices that look to be a real growth area in the medical technology field. These proposed new rules were developed with input by stakeholders, and its guidelines closely follow the health tech industry and community’s recommendations. It’s a model of transparency, public-private cooperation, and regulatory common sense.
I’m John Howell for 3BL Media.
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