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Starting out 2018, Scott Gottlieb issued a new directive to US FDA staff outlining his priorities and vision. Among the directives is to promote digital health and diagnostics by creating efficient pathways for new products in the areas and focusing on technology to help consumers better track their health.



FDA Digital Health



In a roadmap detailing the agency's priorities, US FDA Commissioner Scott Gottlieb outlined several digital health initiatives and his vision for how he wants the agency to work with the sector over the next couple of years.


The agency published a list of the commissioner's priorities for the agency in the coming year, titled, "Healthy Innovation, Safer Families: FDA's 2018 Strategic Policy Roadmap." The document outlines four major priorities, including fighting addiction in the US, with a focus on the opioid crisis; increasing innovation and competition; giving consumers tools to improve their diet and health; and boosting FDA's workforce and ability to more efficiently review products.


"Our roadmap is not intended to be a traditional strategic plan; and it is not an exhaustive list of the important policies that FDA will initiate and pursue over the coming year," Gottlieb wrote in a letter accompanying the document. "In focusing on these selected efforts, we will optimize our resources to achieve clear deliverables that will yield results over the next two years. Publishing this roadmap is another way that we aim to provide more transparency about the FDA’s policy undertakings to all our stakeholders."


With the aim of giving consumers new tools to improve their diet and health, the roadmap highlights the potential of digital-health products, including mobile-health apps, to provide Americans better data on themselves. It states that empowering consumers to make better health decisions means helping them gain access to effective tools that can provide reliable information on their health.


"These tools can include new technologies, such as digital tools and medical apps, which can provide up-to-date health information at the point of decision-making," said the agency. "We are taking new steps to make the development and review process for these novel technologies more efficient."


Gottlieb specifically cites the pre-cert, or pre-certification, program, which is a new pathway FDA is developing to allow health software to get to market based on its level of trust with the developers' development processes. Major companies, such as Apple and FitBit, have already signed up for a pilot to evaluate the program. (Also see "'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What That Means" - Medtech Insight, 26 Sep, 2017.)


FDA's emphasis on digital health aligns with trends in the market, where adoption of mobile technologies into clinical practice is increasing, as more data supports the ability of apps to improve care and lower health-care costs. (Also see "2018 An Inflection Point For mHealth After An Active Year" - Medtech Insight, 8 Jan, 2018.)


"Our work is taking place during an inflection point in both science and policy," Gottlieb said. "We have more opportunity to deliver on the promises of science than at any time before."


Last year, Gottlieb announced FDA's Digital Health Innovation Plan to help the emerging digital-health market. Under the commissioner's new strategic plan, he expands on the Digital Health Innovation Plan and states that FDA should prioritize publishing a final guidance that clarifies what digital-health technologies fall under its regulatory oversight, and advance its ongoing pre-cert pilot program. (Also see "US FDA's New Game Plan For Digital Health" - Medtech Insight, 15 Jun, 2017.)



Diagnostics Policy Reforms Ahead

The roadmap also highlights genomic tests that can give consumers a clearer understanding of risks for certain diseases. And it acknowledges that FDA needs to do its part to help get those products to market.


"Enabling these opportunities means also seeking better and less burdensome ways to reliably validate the analytical and clinical validity of laboratory-developed tests that consumers and providers increasingly rely on," says the report. "To achieve some of these goals, in some narrow cases we are considering complementary and voluntary new programs to encourage product developers to seek the benefits of FDA review through more efficient third-party validation and a new 'pre-cert' review process."


FDA has already moved ahead with some of these models, including for direct-to-consumer genetic-screening services, where the agency has established a "firm-based" approach similar to the pre-cert idea for digital health. (Also see "US FDA Implements 'Firm-Based' Regulatory Approach To DTC Genetic Health Risk Tests" - Medtech Insight, 6 Nov, 2017.) The agency has also laid out a process for leveraging reviews performed by the New York State Department of Health to validate complex laboratory-developed tests. (Also see "A New York Minute: US FDA Leverages State's Health Department To Expedite NGS Reviews" - Medtech Insight, 15 Nov, 2017.)


The commissioner says the agency also plans to talk to Congress about "additional legislative options" to get such products more efficiently to consumers. (Also see "Medtech's Unfinished Business For Congress In 2018: What's Ahead" - Medtech Insight, 11 Jan, 2018.)


Also in the roadmap document, FDA highlighted its efforts to establish an agency-wide patient-affairs staff to implement best practices for patient engagement across product centers, improve consumer search usability of the agency's adverse event database, and improve reporting on issues related to women's health.

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