There are myriad challenges to mHealth innovation and adoption, including antiquated state licensure laws and Medicare policies, as well as a need for the Food and Drug Administration to step up its guidance to the life sciences industry, according to E. Ray Dorsey, M.D.
A neurology professor at the University of Rochester Medical Center in New York, Dorsey (pictured right) spoke about those challenges and others during a June hearing before the subcommittee on Commerce, Manufacturing and Trade.
In an interview with FierceMobileHealthcare, he says he would like to see new legislation approved, including the TELE-MED Act, which would expand Medicaid technology use, and also would like to see Medicare expand telemedicine coverage.
Dorsey also talks about how mHealth policy barriers can be overcome and the direction in which he would like to see the industry go.
FierceMobileHealthcare: In your testimony you mentioned policy barriers. How can these be overcome?
E. Ray Dorsey: The key to eliminating policy barriers is political will, and that has to come from those who stand the most to benefit from mHealth and telehealth applications--patients and their families. Currently, there are more than 50 million Medicare beneficiaries, and in a decade there will be 70 million. If they want to receive care remotely in their homes or on their phones, they can provide the political will to modernize Medicare's policies. Similarly, if the 30 million Americans with a rare disease want to connect to experts in their condition or their child's condition, even if the expert is licensed in a different state, they can provide the political will to force medical licensing boards to act in the interests of patients.
FMH: You suggested in your testimony that the FDA create "affirmative guidance." However, the role FDA and other regulatory agencies play in mHealth has often been confusing. Which agency has the most power to drive mHealth, going forward?
Dorsey: The FDA previously provided guidance on what health "applications" are likely to come under their review, which has helped the industry move forward. If the FDA similarly said we want to see evaluations of new therapeutics that include novel outcome measures, including wearable sensors and smartphone applications that hold the promise of providing objective, sensitive, high-frequency assessments of diseases, that would help the pharmaceutical and medical device industry move forward.
Most important. these new tools must demonstrate that their promise is real, and clinical trials, especially early stage ones, are an excellent place to do so. If successful, sensors can accelerate drug and device development by helping determine whether new interventions are likely to be efficacious in shorter and smaller studies.
FMH: As a physician, what are you seeing on the patient and provider side when it comes to using mHealth tools? What are the top challenges there?
Dorsey: Apple's ResearchKit has galvanized interest in using smartphone applications for research studies. Its first five applications enrolled over 70,000 individuals in seven months--all without a single visit to a research site. We are seeing adoption of these smartphone applications for conditions like rheumatoid arthritis, and also seeing increasing interest in using these to improve clinical care and the conduct of clinical trials. The biggest limitations are the digital divide and retention.
FMH: What changes would you like to see for mHealth down the road?
Dorsey: First, Medicare should expand its coverage of telehealth so that its 50 million beneficiaries can access care wherever and whoever they are. Medicare currently pays about $150 for a clinic visit for Parkinson disease in a hospital-based clinic, about $80 for the same visit in a community-based clinic and nothing for a visit with the same specialist delivered remotely into the home. In essence, Medicare subsidizes institution-centered care and disincentivizes patient-centered care. If veterans, prisoners, Medicaid beneficiaries and military personnel can all benefit from telehealth, so should Medicare beneficiaries.
Second, patients should be able to see whatever clinician they want regardless of geography. This can be done by requiring physicians to be licensed in the state where they are located, by enabling any Medicare beneficiary to see any licensed Medicare provider, or by ensuring that the interstate compact makes practicing across state borders as simple or nearly as simple as driving across state borders.
Third, we need to bridge the digital divide by expanding broadband access and supporting those who are least familiar with the internet, smartphones and their potential applications to health.
Editor's Note: This interview has been edited for clarity and length.