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Roadblocks on the Medical Superhighway?

Medical Device & Diagnostic Industry
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Originally published July, 1996

Thanks in large part to computer-aided medical devices and decision support software, it's only a matter of time before full-scale telemedicine is common practice. Many in the device industry agree that, in the near future, all patient files will be electronically stored, primary-care physicians will be able to easily connect with specialists for on-line consultations, and software programs will analyze increasing amounts of patient data to aid in diagnosis.

While such changes are already in progress, barriers appear to be blocking further expansion of this branch of the information superhighway. According to a March 1996 report issued by the Council on Competitiveness (Washington, DC), one such barrier is the lack of FDA regulations regarding the use of hardware and software in telemedicine systems.

The report, Highway to Health: Transforming U.S. Health Care in the Information Age, states that current policies, which are based on drafts issued in 1987 and 1989, are problematic in that they regulate software as a medical device, even though many of the corresponding requirements are inappropriate for software. For example, current medical device regulations require manufacturers to submit a new premarket notification (510(k)) or premarket approval (PMA) application each time a change is made to a controlled device. In the case of software, which often undergoes fine tuning, gaining continuous FDA approval could quickly prove unworkable for both software developers and the agency.

Recommendations and findings listed in the report stem from the council's one-year study of the health-care market. "We convened an advisory committee of many of today's health-care stakeholders--including physicians, health-care delivery organizations, medical device manufacturers, and insurers--to get their thoughts on how the national information infrastructure can be a significant tool for addressing various needs within the health-care market," explains council vice president Suzy Tichenor.

The report expresses concern that, as a result of the lack of a definitive regulation in this area, physicians and organizations that have developed decision support software tools are refraining from sharing them with others in the medical industry. To prevent this from continuing, the report recommends that FDA set clear limits on when software and other telecommunications infrastructures are subject to FDA regulations. The council also says FDA should work in partnership with medical specialty societies, manufacturers, and cognizant organizations as it develops these policies to ensure that they meet appropriate standards for patient care and are not so restrictive that they inhibit widespread use of these technologies.

Tom Shope, acting director of the division of electronics and computer sciences at FDA's Office of Science and Technology (OST), says the agency is doing just that. According to Shope, FDA recognizes that it needs to make a decision on how it will regulate computer-aided medical devices and stand-alone decision support software. "FDA is drafting a Federal Register notice--likely to be released this summer--that will announce a public meeting to address this issue," Shope says. "This meeting will assist the agency in determining the best approach to risk-based regulation of computer-aided medical devices and stand-alone software."

Harvey Rudolph, OST's acting deputy director, says the meeting--currently scheduled for this September--will attempt to answer the questions of which medical software devices FDA is going to regulate and how. "We may be able to come out with a policy fairly quickly after that," Rudolph says. "As I see it, the lack of a policy is doing more harm than good. People need to know what the requirements are. And even if there are FDA requirements for developers of these products, that doesn't mean those requirements will slow down their progress to market--so long as developers know up front what the requirements are and that the requirements are reasonable."

Still, FDA isn't the only agency that needs to answer questions and develop standards in this arena. According to Highway to Health, another barrier to the rapid advance of telemedicine appears to be a lack of common languages and standards that would facilitate communication and information integration. The report states: "The health-care industry faces a daunting task: to develop common standards that embrace communications protocols, data presentation formats, and data content definition. These must be widely accepted before health care can easily navigate the information superhighway."

So who will set these standards? "It's a decision that's going to be made through the consensus standards process," says Rudolph. He maintains that process should include input from regulatory agencies, manufacturers, and practitioners. "It's the only way that everybody who has a stake in the game can play."

Copies of Highway to Health are available for $25 each. To order, call 202/682-4292. --Romina Vitols

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