Sweeping changes to US digital health regulation?

The US Food and Drug Administration (FDA) is considering overhauling its digital health regulation. Insights finds out about a new pre-certification for software pilot project, which could signal sweeping changes to digital regulation in the US.


The FDA has just launched a new pre-certification for software pilot project, which looks at the developer’s track record in producing high-quality digital health tools, rather than just examining the new products themselves. Additionally, the FDA has just released new Clinical Decision Support guidance.

The FDA came up with the pre-cert pilot programme because it found that the traditional approach to medical product review was lagging behind the innovative technology it was being asked to evaluate. The programme, which could speed up the development of new digital devices, is part of the Digital Health Innovation Action Plan.  Stephanie Caccomo from the FDA’s Media Affairs Office said the pilot could offer a new approach to regulation:  “The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify the company. 

With the information gleaned through the pilot programme, the agency hopes to determine the key metrics and performance indicators for pre-certification and identify ways that pre-certified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal programme. The FDA is also considering, as part of the pilot programme, whether and how, pre-certified companies may not have to submit a product for pre-market review in some cases.”

‘Software that has the potential to benefit health’

The FDA said more than one hundred companies initially volunteered for the pilot study. Bakul Patel, Associate Director for Digital Health at the FDA’s Center for Devices and Radiological Health said it was interesting that so many companies wanted to get involved: “The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health.” 

The agency considered several factors when selecting participants, including company size, demonstrated record of quality and organisational excellence, clinical focus area and the risk profile of the product. The one hundred companies were then whittled down to nine. Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily were chosen. 

Patel explained why he thought it was important to choose a wide range of companies: “The diversity of the pre-cert pilot programme participants means that we will receive a variety of input on how the industry defines organisational excellence and other key performance indicators. This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight.”

According to Caccomo there has been a positive reaction to the programme so far: “We’ve received a lot of feedback. Many parties – including stakeholders, industry, academia – are very enthusiastic about this pilot programme and look forward to receiving updates on the programme as we continue exploring the pre-cert pilot. This pilot is an important first step to help us explore and evaluate which elements might be appropriate for a future pre-certification programme. Once we determine the elements necessary for a future pre-certification programme, we will then look towards the establishment of and broader application of this programme beyond the nine participants to allow other software developers to participate.” 

New Clinical Decision Support software guidance

In addition to setting up the pilot programme, the FDA has also just released new guidance about its plans for the regulation of software that suggests recommendations for healthcare professionals, patients and carers. The main thrust of the guidance is that many types of Clinical Decision Support (CDS) software solutions will no longer be subject to FDA medical devices’ regulation, in particular those that use publicly available data like, for example, guidelines or medication databases. The FDA argues that since users of these CDS tools – think of medication safety alert tools or software that checks whether a patient is treated according to guidelines – tend to be healthcare professionals, who can use their own judgement, rather than follow recommendations, and thus should be able to judge any recommendation given by a CDS tool.

Many parties – including stakeholders, industry, academia – are very enthusiastic about this pilot programme and look forward to receiving updates on the programme as we continue exploring the pre-cert pilot.

The FDA has also clarified that the Office of the National Coordinator for Health-certified electronic health record systems, are not medical devices, but are simply the equivalent of paper medical charts. However, proprietary algorithms will continue to require regulation, suggesting that products, based on continuously evolving algorithms, will be treated as medical devices.

The fact that the FDA is considering making these changes, as well as introducing a new approach to pre-certification, is significant as it shows that the agency is committed to fostering new technology and innovation to improve healthcare. 

Rosy Matheson

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