Federal agencies are taking steps to determine which health IT advancements need regulation — and which do not.

This week, the U.S. Food and Drug Administration publicly sought comments for its new risk-based HIT guidelines, which were published the week before. The framework was required under the Safety and Innovation Act. The report was created with the Office of the National Coordinator (ONC) for HIT and the Federal Communications Commission (FCC).

In short, the FDA won't be regulating anything that it does not oversee already, but it has recognized new IT tools and established a position on the level that it will govern them.

"FDA is basically saying that they do not see any need to enlarge their responsibility over health information technology. I think most people agree with that," Bradley Merrill Thompson, a lawyer who counsels medical companies on FDA-related issues with Epstein Becker Green in Washington, D.C. told DOTmed News.

Instead, the federal government, and specifically the Department of Health and Human Services (DHHS) is proposing that the ONC play a leadership role in overseeing the safety of moderate risk health information technology, he said.

The report establishes three health IT categories centered on product function instead of its operating platform. So for instance, IT applications and tools aren't put into categories based on whether they exist on a mobile or cloud platform. Instead, they are categorized based on risk to the patient.

Category 1: Products with administrative health IT functions
The FDA will not regulate products with administrative health IT functions, such as billing, claims processing or inventory applications.

Category 2: Products with health management health IT functions
The second category includes software for health information, data management, provider order entry, medication management, knowledge management, electronic access to clinical results, and most clinical decision support tools. If these products meet the definition of a medical device, the FDA will not regulate them. The category also includes tools for testing, certification and accreditation.

The report suggests relying mostly on ONC-coordinated activities and private manufacturers to create quality products. The agencies will favor IT stakeholders to identify the essential elements of a quality product, instead of taking a formal regulatory approach.

Most clinical decision support software falls into this category, but not all. That's where Thompson would like to see more information.

"Many in industry have been waiting for years to find out more specifically the distinction between wellness and disease, exactly what constitutes medical device accessories, exactly what constitutes clinical decision support software that FDA would regulate, and parsing medical device software modules for regulation," Thompson told Health Data Management.

"The report explicitly mentions all of those areas and says that they will be the subject of further clarity, and outside of the report obviously the agenda for 2014 for FDA includes those items," he said. "But I would like to have seen more in the report about where the agency plans to go with regard to those items."

Thompson says one important part of the report is that it proposes taking steps to facilitate the interoperability of medical devices and health IT, an important part that's been left out of other HIT policy initiatives.

Category 3: Products with medical device health IT functions
This is the most high-risk group, that could pose great risks to patients. According to the report, the FDA would continue to regulate items such as software for bedside monitoring, radiation treatment and computer-aided detection.

"This proposed strategy will facilitate innovation, protect patients and support FDA's focused oversight on higher-risk technology, similar to medical devices that are currently regulated," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

Creating a Health IT Safety Center
The report calls for ONC to form a Health IT Safety Center in partnership with the FDA, the FCC, HHS' Agency for Healthcare Research and Quality (AHRQ), and other organizations. The Health IT Safety Center would work on best practices and provide a forum for the exchange of ideas and information focused on patient safety.

"The draft report reflects FCC's narrow but important role in encouraging new and innovative wireless medical technologies and ensuring that developers and users of these technologies are minimizing the potential for causing potentially harmful interference to radio services," said Matt Quinn, the FCC's director of health care initiatives.

Report stirs different viewpoints
"The bottom line is that HHS, and the three agencies, are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for HIT developers," Thompson said in a written analysis.

"My primary criticism of the plan is that it doesn't move very aggressively to define exactly the dividing line between the software that FDA does in fact regulate and that which it doesn't," he told DOTmed News.

"For a few years now, folks in industry have been asking FDA to define that line with greater clarity. FDA has that project on its to-do list, but has been very slow to respond," he said. Thompson adds that the plan acknowledges the need to move forward, but provides "no details on how or how fast" it will do that.

The Medical Imaging & Technology Alliance (MITA) praised the report, which determined that the FDA will continue to be the regulating body for the medical imaging informatics field.
Gail Rodriguez, executive director of MITA, said it will promote innovation in HIT products, avoid regulatory duplication and protect patients.

"In a fast-paced, technological world, it is critical that regulatory frameworks support the implementation of innovation for patients," Rodriguez said.

While there was regulation of HIT before, this report creates a clearer regulatory structure, according to Rodriguez. "HIT is very complicated and diverse so this is a very welcome development," she said.

Joel White, executive director of the Health IT Now Coalition, said in a statement that he was pleased the report addressed the needs for "interoperability of technologies to improve safety."

"It also includes suggestions for a better environment for reporting medical errors and problems associated with technologies," White said. "These suggestions are steps in the right direction toward creating a risk-based framework, based on a technology's functionality, so these innovations can safely and effectively improve patient outcomes and lower costs."

The agencies will seek comments and schedule a public meeting within 90 days before adopting the guidelines in the report.