The Food and Drug Administration (FDA) is currently seeking public comment on its draft framework for regulating health IT, released earlier this month as required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). The document, which has produced conflicting opinions and concerns about the role of regulation in a market that relies on nimble innovation for vendor success, has attracted Congressional questions and industry-wide speculation even before its long-delayed appearance.
“While health IT benefits are far-reaching, technology can bring risks to patients if not designed, developed, implemented, or maintained properly,” Bakul Patel, Senior Policy Advisor to the Director of the Center for Devices and Radiological Health at the FDA, wrote in a blog post. “In health IT, the best approach is a risk-based approach. We believe risk assessment should primarily focus on the function of the health IT product, not its platform.”
Patel divides health IT into three major categories, including administrative products like EHRs and practice management software, health management products such as CPOE and patient identification products, and the highest risk category which directly impacts patient care. “FDA intends to focus our attention on the third category, which relates to medical device functions, such as computer-aided detection software and radiation treatment software,” he says. “Such products are already FDA’s focus because they generally pose greater risk to patients than the products in the other two categories.”
While Patel states that the FDA is not recommending that new areas of oversight fall under its control, developers have continued to express fears that the administration’s involvement in medical devices will stifle innovation and make it more difficult to bring products to market in a timely manner. “Along with ONC and the Federal Communications Commission (FCC), we will continue to develop this framework through public engagement, especially in fostering the further development of a quality-focused culture for health IT. We do not believe that regulation should be, or needs to be, the first approach used to reach this outcome,” Patel stresses.
In order to give industry stakeholders an opportunity to comment on the framework, the FDA, ONC, and FCC will be hosting a public workshop May 12 through 15 at the National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland. Patel invites consumers, developers, providers, and other interested parties to register for the conference or watch the simultaneous webcast online during the three-day meeting. Stakeholders can also submit their comments through an online form.