This week, I had the privilege to present at the Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade Hearing that took place in Washington, DC. As part of the “Disrupter Series: Health Care Apps” hearing, leaders in the healthcare industry discussed how mobile applications are disrupting the ways in which doctors and patients engage in the health care system and impact the affordability, accessibility, and delivery of care.
As part of my participation, I prepared a written testimony – part of which is excerpted below –advocating for interoperability and an increased collaboration with government entities to foster an environment that encourages innovation and care transformation. As we look to collaborate with key stakeholders across the connected health ecosystem, it is critical that we identify outdated health regulations, incentivize the use of advanced technological solutions, and ensure patients and consumers can see improvement in their health.
The Landscape for Mobile Health Applications
Health systems and physicians face complex reimbursement models and payments increasingly aligned to value as opposed to fee for service. After waves of traditional cost cutting to preserve financial margins, providers realize that remaining gains can only be achieved through care transformation – shifting quality care to lower cost settings using novel human and technological resources. Connected health technologies…demonstrate that innovative solutions can reduce costs and improve care quality and engagement. Healthcare must and will look significantly different going forward.
Fostering an Environment for Innovation
Given the pervasive nature of mobile technology broadly, hopefully similar approaches will flourish in healthcare. I humbly offer suggestions to foster this path.
- Enforce interoperability – HHS and more specifically the Office of the National Coordinator (ONC) for Health Information Technology have an opportunity to focus on and enforce meaningful interoperability as opposed to pushing a future standards-based agenda that will not meet the needs of the market today. Specifically, there is messaging that the third stage of meaningful use (requiring portability of data to consumer facing applications) will address interoperability challenges but this is not completely thought through. Creating consumer-facing applications that allow patients to assimilate all of their healthcare data will not be enough to solve the workflow challenges of those who care for them. When a patient shows up to an emergency department as part of an ACO and all incentives are aligned on preventing an avoidable admission of that patient to the hospital, the emergency room doctor needs a solution that works for them. Consumer facing applications will absolutely fall flat in this setting. As a minimal initial step, HHS should promote true interoperability via open, affordable, complete, bidirectional application programming interfaces by withholding incentives and innovation grant funding for any applicants who are not using vendors that comply.
- Create a “hot-line” between innovators, health systems, and the FDA – The greatest benefit of having a long history of clearance with the FDA when it comes to mobile health applications is the opportunity for dialogue. Innovation will always outpace classification and regulation. Therefore, real-time dialogue is essential to expedite classification and clearance….[C]areful regulation is essential for mobile health applications that are in the realm of near real time monitoring and clinical decision support. That said, innovation by definition will blur all lines and therefore expanded resources are needed at the FDA for thoughtful dialogue, problem solving, and co-navigation to clearance. The FDA should be viewed as an innovation and safety partner and not an obstacle.
- Help clarify the markets of “consumer driven” and “health system driven” mobile health applications – There is great confusion about what mobile health means. To some, it involves consumer oriented body sensors and applications focused on fitness and wellness in the absence of clinician supervision. To others, it involves FDA regulated body sensors and applications involved in the remote delivery of healthcare. The former market is important and will be consumer directed and paid for. This forms the leaves of the health care delivery tree. The latter market is equally important and will be directed and paid for by providers, payers, and joint collaboration risk-bearing entities like ACOs. This is the trunk of the tree. Different policy and regulatory standards are likely appropriate and should be clarified broadly for those innovating in the marketplace. As a threshold issue for subsidized medicine, CMS cannot continue to rely on Medicare’s over 15-year-old definitional restraints on “telehealth” in 42 CFR 410.78 to serve as a definition of telehealth. To shift to a value-driven approach, the Medicare system must leverage the wide array of advanced connected health technology solutions available today, as well as future innovations we cannot predict, by evolving its telehealth definition to one that takes a technologically-neutral approach to the use of connected health and provides the flexibility for eligible practitioners to appropriately utilize the range of these solutions, lowering costs to Medicare while vastly improving patient care.
- Incentivize and fund efforts to prove value – The traditional method of randomized controlled clinical trials, or the FDA investigational device process, to prove efficacy are extremely difficult to apply to the fast paced world of mobile health application innovation. Innovators would benefit from dialogue with government and health system partners on how best to demonstrate value so that appropriate, fast paced initiatives can be funded and publicized for others to learn about clinical and operational benefits of mobile health application technology.
- Feed the pipeline of software developers – Any efforts to promote the interest and education of future software developers in the realm of healthcare technology would be widely welcome.
Mobile health technologies create incredible benefits to the American healthcare system, but their full potential cannot be met without a careful and coordinated effort between Congress, federal agencies, and the industry as a whole. Without meaningful action to address important issues like interoperability, market clarity, agency efficiency, and the talent gap, we risk the quality of care physicians can provide patients.