FDA seeks public input on health IT regulation framework
The government mandate of the widespread use of new technologies in health care has frustrated many physicians and other front-line professionals. Meaningful use requirements have seen the use of electronic health records skyrocket alongside workflows as staff members work to become familiar with the new software. Some physicians have criticized data entry methods that reduce them to simple typists while decreasing the time they can spend with patients.
Though physicians may have felt shut out from much of the policy-making process in the past, recent actions from the U.S. Food and Drug Administration, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission may indicate a larger voice of health care professionals in future regulatory measures. According to a report written by the three agencies and released by the FDA, a new standardized framework for regulations regarding health IT will attempt to forefront the experiences and expertise of the industry as all parties move toward greater security requirements for EHR systems, smartphone applications and any other technology that may emerge.
Reviewing the report
With an influx of mobile health apps and the continued increase of EHR use across the health care community, the FDA, ONC and FCC are moving forward with plans to codify best practices in relation to securing sensitive patient data in the digital world.
Released April 3, the report explained that regulations for technologies should not be approached from a platform-centric schema that applies blanket policies to all smartphone apps, for example, but rather each individual technology should be evaluated based on the amount of risk patients face when they enter personal information into the respective systems.
As for how best to achieve such a detailed regulatory response, the agencies will turn to health care professionals who have the experience and knowledge necessary to craft intricate policies regarding these individual technologies. The report indicated that independent, nongovernment programs and committees would be formed to create suggestions that would then be implemented into official regulations from the agencies.
Bradley Merrill Thompson, a member of health care litigation firm Epstein Becker Green, told Healthcare IT News that this hands-off approach to creating regulations gives health care professionals more options and the opportunity for more of a say.
"The bottom line is that [the Department of Health and Human Services], and the three agencies, are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for all of the [health IT] developers producing wonderful, important, cutting-edge new technologies," Thompson said.
Voicing opinions
Though the FDA, ONC and FCC have promised to create an inclusive environment prior to the regulations' implementation, some health care professionals may worry that their views will not be represented by a handful of small committees and think tanks.
For physicians in small practices with especially poignant views on how technology should be handled by federal agencies, the FDA has created an online portal where any member of the public can submit comments, criticisms and concerns about the pending policies. The submission period ends July 7, 2014.
Bakul Patel, senior policy advisor for the FDA's Center for Devices and Radiological Health, told Health Data Management that the agency is not putting regulations on EHR systems or smartphone apps ahead of industry input on those technologies.
"The unique aspect of health IT, that other people are raising, is exactly what we considered," Patel said. "Having a public-private partnership, we actually come out and say we think and believe that the regulatory approach is not the first step. We need to bring in the stakeholders creating a framework that's unique and applies to health management health IT."
