Skip to content Skip to footer

Loading Results

Four regulatory pathways that could accelerate digital health

Start adding items to your reading lists:
Save this item to:
This item has been saved to your reading list.

Alexander Gaffney Senior Manager, Health Research Institute, PwC US September 16, 2019

Recent changes made by the FDA have made it easier for digital health products to be cleared and approved, offering life sciences companies – and pharmaceutical companies in particular – the opportunity to accelerate approvals and improve provider and patient satisfaction. Companies willing to invest in strengthening or building digital competencies may win market share, while those without sufficient investments may find themselves at a disadvantage.

Four regulatory changes, as well as a host of smaller changes, are creating new opportunities for the pharmaceutical sector.


Digital health precertification

The FDA is advancing a new regulatory approach to digital health called the Digital Health Precertification (Pre-Cert) program. Now in pilot-phase testing with nine companies, the approach aims to make reviews of digital health products more efficient by rewarding companies assessed and evaluated by the FDA as having a “robust” culture of quality and organizational excellence for the purposes of developing digital health products.

Those companies will be permitted to have their products reviewed in a streamlined way, which would reduce the review time for the product by focusing on what the product is rather than what it does. This would then be paired with real-world health analytics, product performance analytics and user experience components, requiring the company to track how the product is being used and quickly address issues.

The FDA plans to begin expanding the program to additional participants in 2019, and the model could eventually become the way in which many digital health products come to market.

Critically, the Office of the National Coordinator for Health Information Technology (ONC) has said that companies participating in the Pre-Cert program will be exempt from some elements of its Health IT Certification program’s requirements for testing and certification of health IT.

Devices with multiple functions

The FDA has published draft guidance that would make it easier for companies to include multiple functions in their mobile applications. Some devices, for example, may include a complex prescription function intended to help diagnose disease, like an algorithm that detects signs of cancer from a photo, as well as some unregulated functions intended to benefit the end user like a step counter or diet tracker.

Rather than treating all of the functions of the device as a single, combined entity, the FDA will instead treat them as separate. This will permit a regulated device to include otherwise unregulated or minimally regulated functions without subjecting them to rigorous oversight by the FDA. This could help companies to develop, upgrade and update more full-service applications without having to worry that each added function would trigger new regulatory requirements. It could also help companies to develop products in an iterative manner, allowing them to incorporate patient feedback into developing more useful products.

Companion applications as labeling

The FDA has proposed a substantial change in the manner in which it will subject pharmaceutical companies’ drug-use-related software to regulatory oversight. Such applications include companion mobile applications that help consumers to use a company’s prescription drug products in accordance with the FDA-approved labeling.

Previously, companies could be required to submit these applications for approval under the premarket notification pathway, also known as the 510(k) pathway, if they were not exempted. Under the new proposed change, the FDA would instead treat such applications as promotional labeling, a much lower standard of review that does not require FDA approval prior to dissemination.

This could greatly increase incentives for companies to develop digital companions for their products by lowering the regulatory hurdles for entry.

It may also find a ready audience with clinicians. Forty-five percent of clinicians responding to a 2017 survey by HRI reported being somewhat willing to prescribe mobile apps to patients, and another 24 percent said they were very willing to do so. Responses varied significantly, however, depending on practice type. For example, 17 percent of medical specialists said they would be very willing to prescribe a mobile app, while 43 percent of those working in community health would. Twelve percent of those working in an urgent care center would be very comfortable prescribing, while 45 percent working in a federally-qualified health facility would.

Fifty-six percent of physicians surveyed in 2018 said they have discussed an app or digital program with their patients in the last 12 months (see Figure 2). However, just 14 percent of consumers said they had ever been prescribed a mobile health app, of which 50 percent could be categorized as frail, elderly patients.

Fifty-six percent of physicians surveyed in 2018 said they have discussed an app or digital program with their patients in the last 12 months.

New OTC drug approvals

In July 2018, the FDA released draft guidance saying the agency is willing to allow the approval of over-the-counter drugs that it would otherwise not approve – as long as they have the right type of product labeling, which could include digital labeling on smartphone apps accompanying the drug. Under the FDA’s approach, these digital tools – primarily mobile applications – would help consumers choose OTC drugs that would be best for them and avoid drugs that could harm them. Companies would be required to conduct studies of the application to ensure it correctly steers consumers to or away from its product.

The FDA said it believes the new approach could support the approval of a “wider range” of nonprescription drug products than is on the market, which could benefit pharmaceutical companies with long-marketed, generally safe products with minor safety concerns that have prevented them from obtaining OTC approval.

The use of digital labeling is likely to have an impact on some, but not all, consumers. Thirty-two percent of consumers surveyed by HRI in 2018 reported having used a mobile device to look up information about symptoms, conditions, diseases and treatments. This type of activity could expand with the support of the FDA and industry, however.

Separately, both the House and Senate are considering legislation that would overhaul the manner in which OTC drugs are approved in the U.S., shifting to a system in which products would be approved based on administrative orders instead of through a notice-and-comment rulemaking process. This could potentially shave months and even years off of the regulatory review process, and, paired with the digital health component, create new opportunities for companies to get new OTC drugs to market more quickly. The FDA said it plans to hire significant numbers of new staff to review products, and that products will be reviewed within 17.5 months of the date of submission. Versions of the bill have previously passed the House and Senate.

For more on this topic, read the HRI Report, Acceleration by regulation: Pharma stands to benefit from the FDA’s digital health approach.

For more of HRI’s insights and content, visit our Regulatory Center and report library

Contact us

Alexander Gaffney

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Benjamin Isgur

Benjamin Isgur

Health Research Institute Leader, PwC US

Follow us