Digital health products need evidence and buy-in to succeed

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US April 10, 2019

New regulatory pathways for digital health may simplify market access and product development cycles, but companies will still need to take stock of how they can best leverage digital health with their new or existing product portfolios, and the data that will be necessary to support these products.

Digital health products must ultimately be designed with their users and their unique needs in mind. A product that is not useful to, or usable by, a patient will not be effective no matter how good the product is otherwise. A product that does not integrate into physician workflows in a straightforward way may not be prescribed. For companies developing digital health applications and products, their focus should be on how to treat patients in ways that go beyond a single dimension of health.

According to research published in the journal Health Affairs, even well-funded companies often lack clinical evidence supporting the use of their products. Of the top 20 digital health companies by funding, nine companies lacked any peer-reviewed evidence, and 28 percent of the studies conducted on the companies’ products looked at high-risk or high-cost patients.

Are you developing a solution or a therapy?

For companies, the focus should be on the type of digital health product to develop, and whether they are developing solutions or therapies.


Solutions can be thought of as nonprescription applications that don’t require FDA approval but add value for patients, while therapies are physician-prescribed products supported by clinical data and reviewed by the FDA that may also be reimbursed by an insurer. While the former are easier to get to market, digital therapies may ultimately offer more value to companies and their customers. High degrees of competence can help companies get products to market more quickly, increase market share and help companies create ties to physicians and patients that go beyond the pill.

These ties can become integrated into clinical practice, making it less likely that doctors or patients will want to switch to market competitors when generic or other competition comes onto the market.

How companies can use digital health to meet consumer needs

Thirty-one percent of patients surveyed by HRI in 2017 said they wanted medication with proof of good outcomes and few side effects and rated it as a “most important” part of their care, and another 22 percent said they wanted help managing their medications.

Digital health applications and tools can help providers to meet these consumer goals, but first companies will have to identify those needs and then create the tools with which to meet them.

Pharmaceutical executives told HRI they believe they know which elements will be important, but many companies have not yet met those needs.

Digital health products need evidence and buy-in to succeed

Similarly, generic companies or competition can use digital health tools to make inroads into therapeutic areas for which good digital health tools are lacking. The ONC’s certification stance means companies who are willing to put in the work on digital health certification can find it easier to get their products integrated into provider workflows and clinical trials.

Good digital health tools can also be critical for payers, and in particular those engaged with value-based contracting. If companies are able to generate evidence about their product, improve rates of adherence or improve outcomes for a patient using digital health applications, that could improve its value and help drive more favorable reimbursement rates for the product.

Companies may also find it beneficial to work together on common approaches to data. In comments to the FDA, the American Pharmacists Association suggested that when it comes to prescription drug-use-related software, “processes and systems must be standardized and interoperable” to ensure the use of the software doesn’t “disrupt or disjoint” care.

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


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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

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