Healthcare professionals are calling on the federal government to eliminate barriers to mobile healthcare development, create better data security and privacy rules and foster a supportive environment for advancements in mHealth tools.
“Policy barriers, especially antiquated state licensure laws and Medicare policies, limit [mHealth] adoption and access to care,” E. Ray Dorsey, M.D., professor of neurology at the University of Rochester Medical Center, said during a hearing Wednesday held by the Subcommittee on Commerce, Manufacturing, and Trade.
Dorsey said he believes the U.S. Food and Drug Administration should offer “affirmative guidance” to the life sciences industry, encouraging and supporting mHealth tech adoption, and that Congress and the president should embrace and approve new legislations. That includes the TELE-MED Act, which would expand Medicaid tech use.
Dorsey was one of six witnesses who spoke during the hearing, which focused on regulatory involvement in defining and classifying apps, legal hurdles stalling development and adoption, app safety and effectiveness, and data privacy and security, among other topics.
“One of the hurdles we face in advancing the development of our technology is the uncertain future landscape of telehealth and how the FDA will classify and oversee such tools as medical devices,” said Laura Ferris, M.D., assistant professor in the University of Pittsburgh's Department of Dermatology.
Mobile healthcare company AirStrip's president, Matt Patterson, M.D., in his testimony, urged federal agencies to target and enforce interoperability, which he believes is a big obstacle. He said they should also avoid a standards-based agenda because it doesn’t fulfill market needs.
“What is needed most is an open landscape for systems to talk to each other in a manner that gives clinicians and consumers the information they need in near real-time so they can make the right decisions,” he said.