Life sciences companies and Big Pharma have already jumped on to the digital health bandwagon by developing apps and products directed at improving the patient experience.

Recent changes by the FDA are poised to make it easier for these companies to gain accelerated approval for digital health products in their pipeline. The upcoming products are geared both for health care providers and patient satisfaction. The new regulatory pathways for digital health products are designed to simplify processes concerning product development cycles as well as market access.

However, gaining approval will not be possible without showing data in support of the app or product, and companies will still need to reckon with how their current or upcoming products will fare with end-users.

Criteria for digital health products

In order to be marketable and viable, digital health products will have to be

• designed with their users and their unique needs in mind. Because, a product, no matter how brilliantly put together, marketed, or well-funded, will not stay viable if it is not useful to the end-user.
• able to integrate into physician workflows in a straightforward way. Otherwise, it may not be prescribed.
• versatile. The best ones should be able to help patients in ways that go beyond a single dimension of health.
• able to generate clinical evidence in their own support, to be considered by regulatory agencies for approval.

Digital health solutions v/s therapies

Digital health solutions are nonprescription apps. Not being a medical intervention, they do not require FDA approval as such, but they add value for patients.

Therefore, they are easier to bring to the market.

Therapies, on the other hand, are physician-prescribed products. They have to be supported by clinical data and undergo FDA review and approval processes before getting the green light. They can even be covered under insurance.

RTherefore, they may bring more revenue and be of more value to their makers and their customers. There is more investment in making them marketable and viable, but they can help the companies capture market share as well as mind share with healthcare providers and patients.

What type of digital health products are in the works?

Pharma companies are interested in developing these categories of digital health products, most of which fall under the "solutions" category.

• Patient support and education tools, like mobile apps
• Treatment adherence and compliance programs
• Remote patient monitoring
• Smart devices
• Data sharing with care providers
• Tools and support aimed at caregivers
• Prescription drug-related software

Caregivers' take on digital health apps and products

Clinicians surveyed in 2017 are mostly tipped in favor of prescribing mobile apps to patients, with 45% being "somewhat willing," and another 24% being "very willing." The type of clinical practice, however, is a major differentiating factor. Only 17% of medical specialists and 12% in urgent care were reported to be "very willing," as opposed to 43% of those in community health and 45% working in a federally-qualified healthcare facility.

How new OTC drug approval will impact digital health solutions

Image by Digbi Health

In July 2018, the FDA had released draft guidance saying that it will allow approval of over-the-counter (OTC) medicines that it would not otherwise, provided they have appropriate product labeling. This may include digital labeling via digital tools such as smartphone apps that accompany the drug. These FDA-approved digital tools would also help patients choose the most helpful OTC drugs and know which ones they should avoid. Needless to say, the companies that design these apps would need to conduct extensive studies to verify this effect and demonstrate that this effect is accurate and replicable under various circumstances.

The American Pharmacists Association feels that any software that pertains to prescription drug use should be built upon processes that can be "standardized and interoperable." This will, in turn, ensure seamless patient care and be recognized as a safe means of intervention.