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The Evolving DigiMed Regulatory Framework

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The FDA is continuing to fine-tune its approach to regulating digital medicine, with a change in its approach to regulating digital health solutions. After focusing largely on defining the scope of FDA regulation for a number of years, the agency is now moving to finding better, more efficient ways to regulate already-regulated digital products. The Digital Health Software Precertification (Pre-Cert) Program is an example of that.

Pre-Cert: A work in progress

The Pre-Cert Program is an important component of the Digital Health Innovation Action Plan, and is the FDA’s attempt to understand IT industry best practices and to apply them to medical device development, and thus better assess the safety and effectiveness of software.

“The Pre-Cert Program is still a work in progress and hasn’t yet been pilot tested,” points out Yarmela Pavlovic, partner with Hogan Lovells’ FDA Medical Device group. Instead, it’s in its final iterations of initial development.


The agency accepted nine technology companies (Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily) into a “pilot” for the program and spent approximately one year gathering information from them to learn more about how they develop and maintain software.

“The FDA took that information and developed a high-level working model—a first draft—of what the Pre-Cert Program should look like,” she continues. “The operative question was whether regulatory focus could be shifted to the company from the product if the company has good practices and procedures in place.”

A few months ago, the FDA released a second version of the working model. By the end of Q1 2019—possibly by the end of 2018—the FDA has committed itself to releasing a final working model, dubbed Pre-Cert 1.0.  That model will then be used as the basis for an actual pilot of the program.

According to the FDA, that version will be available for manufacturers of software as a medical device (SaMD), though it is unclear whether any companies beyond those in the pilot will be able to participate. As the agency gains experience in pre-certification, it plans to expand the program to include software in a medical device (SiMD) and software it considers an accessory to a medical device.

 [See how the Hogan Lovells team is securing against cyber threats in the Digital Medicine Report]

“We know a lot about the idea behind Pre-Cert and some of the expected benefits, but we don’t know much about the proposed costs,” Pavlovic points out. For example, the program calls for companies to provide more in-depth post-market surveillance data back to the Agency. Details regarding the extent of surveillance, what infrastructure will be needed, whether companies have that infrastructure, and what that surveillance will cost are unknown.

“In addition, although FDA is proposing streamlined review of marketing applications, it appears that this may be intended to be used only after significant pre-submission interactions,” she says.  “For some technology companies, that could be more efficient. For others, it could potentially lengthen time to market. Getting more certainty around the plans, expectations, and timelines is needed,” Pavlovic says. “On the balance, I think the outcome may be neutral.”

IT is ready for medicine

Much has been said about the noted cultural differences between IT and life sciences companies and how those differences may affect digital medicine development. Those concerns are no longer indicative of the digital medicine industry, Pavlovic asserts. “Digital medicine isn’t a fledgling space anymore. The industry is mature and folks are very savvy about the specifics of digital health.

“The digital health industry is evolving constantly,” she continues. With technology, rapid iterations are possible and, in fact, desirable. Both tech and pharma are realizing how responsive that ability makes digital solutions. It allows not only digital health products, but digital health business models, to adapt immediately to changing conditions. Changing use cases and responses to cyber vulnerabilities are just two examples of areas in which the ability to rapidly iterate confers a business advantage.

Investor interest in regulated devices grows

“A few years ago, investors wanted nothing to do with technology that required FDA regulations,” Pavlovic recalls. “Those technologies, with some exceptions, often didn’t have highly successful business models.” Consumers weren’t willing to pay out of pocket for things used for their own healthcare and such tools weren’t commonly reimbursed by insurance.

Realizing this, investors decided to not make FDA regulation a gating mechanism for their investments. Instead, they began to focus on funding technologies that could solve real problems. “Those technologies tend to fall in the regulated space,” she explains. “The investment community around digital medicine has matured so that you now see a flow of investment into FDA-regulated products.”

Some see regulation as a benefit. “Regulatory approval is a way to publicly demonstrate that the company has something to support its claims,” Pavlovic says. This provides a bit of comfort to developers, too, by ensuring that someone else with expertise also scrutinizes the technology before it’s released. For disruptive companies and technology, regulation also serves as a bar to entry that slows competitors’ abilities to catch up.

What to expect in 2019

In 2019, Pavlovic says she expects the FDA to launch Pre-Cert Program 1.0 as a pilot program. “We’ll also see the continuing evolution of the FDA’s own learning around digital medicine. Cybersecurity and machine learning will be big areas of growth.” This is true for both the industry and the agency. For example, “both the agency and industry are looking at ways to safely allow machine learning-derived models to evolve over time with access to new data.  Real-time learning may lead to stronger products, but it is important to fully vet the training data used and the potential biases those datasets could introduce,” she says.

The agency also plans to modernize its 510(k) program to ensure the most current standards are used for clinical and non-clinical validation. “This isn’t specific to digital health solutions, but it affects these products,” she says.

As companies navigate the shifting regulatory ecosystem of digital medicine, Pavlovic advises them to “focus on the narrow space of your technology, and understand the precedents within that space. Engage with the FDA early in meaningful discussion. Provide details and specific proposals. The more details you can give the FDA, the better the feedback.”

Join Yarmela Pavlovic and other speakers at Digital Medicine & Medtech Showcase in San Francisco January 8, where a panel will explore the changing regulatory landscape for digital medicine.


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