NEW ORLEANS—The proliferation of mobile medical devices and apps haven’t come without considerable scrutiny from various federal agencies. Scott A. Edelstein, JD, MPA, partner and Mark D. Johnson, JD, senior attorney both at Squire Sanders, discussed the legal issues in the converge of healthcare and mobile telecommunications during an educational session at the Health Information and Management Systems Society (HIMSS) annual convention.
The Patient Protection and Affordable Care Act brings many more newly insured Americans into the healthcare system along with demands for physicians, Edelstein said. That means a need for access. “Unfortunately, the regulatory environment has not kept pace with the advent of technology. It’s a grey area. There is not a lot of certainty about how to navigate the legal issues.”
The FDA regulates medical devices intended for the use in diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, he explained. That is a very broad definition but a lot of what mobile app manufacturers are doing fits into this definition.
The agency is going to regulate a subset of apps, Edelstein said: those used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device. Currently, just draft regulations exist but those provide a sense of where the FDA is going. After many received comments, Edelstein said he hopes to see final guidance in the near future.
Meanwhile, telemedicine means healthcare no longer need follow the hub-and-spoke model. However, issues such as licensure have a huge impact. There are 50 different state laws governing physician licensure so reimbursement, confidentiality, liability and more make it a bigger and bigger issue, Edelstein said. “What happens if there is an adverse event? Who is responsible?” Interstate practice gets very complicated.
Another question to consider is malpractice and general liability, he said. When is the physician-patient relationship created? No clear answer is causing problems. “We’re starting to see lawsuits in this area.”
Which standard of care applies? “There is not a lot of precedent for this." It is yet to be worked out under which jurisdiction lawsuits should be heard. Meanwhile, “I am surprised how many of my clients have not looked at their malpractice contracts. There is an assumption of coverage but in most cases, they are not covered. That is usually a provision for licensure.”
Patient consent is an area in which the Federal Communications Commission (FCC) is interested, Edelstein said. Has the patient received enough information to make informed consent? And, recording of patient encounters is a “double-edged sword. If you’ve met the standard of care, a recording can serve as a terrific shield in your defense. On the other hand, if you have not met the standard of care, the recording can be used against you.” Think through the issues before you record, he advised, and consult with your counsel and malpractice carrier.
There is so much convergence happening that more knowledge of the telecommunications industry is advised, said Johnson.
Radio spectrum enables mobile health, he explained. However, spectrum is a finite resource and wireless devices use multiples of additional spectrum “putting incredible pressure on the ability to utilize existing spectrum resources and advance technology.”
Federal agencies have embraced, encouraged and supported the proliferation of mobile devices, he said, but there are several key issues such as interoperability, reliability, connectivity and privacy and security.
The FDA Safety and Innovation Act requires the FCC, the FDA and the Office of the National Coordinator for Health IT to propose a strategy and recommendations to create a risk-based framework for health IT. Meanwhile, just this year the new Healthcare Connect Fund was announced to expand healthcare provider access to broadband with $400 million on the table for the first year.
The FCC has been very active in setting aside particular spectrum for mHealth activities separate and apart from WiFi spectrum, Johnson said. The agency recently created the Medical Micropower Network, made up of low-power wideband networks. Medical body area networks are restricted to indoor use in registered medical facilities. A low-power wideband network of multiple body-worn sensors was released in 2013, as an experimental medical testing license to enable testing of new radiofrequency medical devices.
“There have been many complaints over the years that the FCC has been too slow,” Johnson said. This new network was created just for the medical community and is available only to healthcare facilities with radiofrequency expertise. Also new in February is new broadband spectrum and a proposal to provide an additional 195 MHz of new frequency at 5 GHz.
“There are a lot of competing forces for spectrum,” Johnson said. “It’s incredibly valuable.” The FCC wants to ensure that spectrum is put to its highest and most valuable use with maximum efficiencies, maximum utilization and minimal risk of harmful interference.
Unclear regulatory framework adds to the challenges. The FCC’s privacy protections apply only to communications carriers and the FDA’s authority reaches only medical devices or where they contribute to the clinical decision-making process. When does an app become a medical device when there is no doctor participation or FDA approval? Johnson posed. Meanwhile, the FTC has broad consumer protection authority to which the other bodies usually defer. Mobile app privacy guidance is out this year as well.
Much remains to be sorted through but it’s clear that “unique legal issues are implicated by these types of apps.”