No shortage of public comments on FDASIA draft report

Several stakeholder organizations submitted comments representing mixed opinions on the risk-based health IT regulatory draft framework just in time to meet the July 7 deadline.

The Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA, the Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission to develop "a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT including mobile medical applications that promotes innovation, protects patient safety and avoids regulatory duplication."

To that end, the Department of Health & Human Services released a draft report in April that included a proposed strategy and recommendations for creating the framework and sought public opinion on the FDASIA report.

In an article on its website, HIMSS said it generally agreed with each of the proposed principles, offering comments on each of the three proposed categories and observed that a potential fourth category could be incorporated that would include pharmacy, diagnostics and procedural health IT functions, with areas of focus including medication management, radiology, labs and surgery. "These areas are related to health IT management particularly through integration with EHRs but also EHR interfaces," the organization wrote.

HIMSS agreed that a "Health IT Safety Center should operate within the scope outlined in the draft report—not as a regulatory or oversight body, but rather focus on gaining evidence and knowledge without specific implementation responsibility. We suggest that the Center should operate transparently, with clear roles for public and private sector participants, open meetings and potential opportunities to review drafts of policies." HIMSS recommended drawing on the experience of ONC’s Federal Advisory Committee process and suggested working with other safety reporting initiatives and pilots underway currently to learn from examples on how to effectively operate within the healthcare arena. 

The American Hospital Association (AHA) said that it opposes the framework and instead supports "existing safety reporting requirements and initiatives."

AHA Senior Vice President for Public Policy Analysis & Development Linda Fishman signed off on a letter that called for a framework that highlights three main components:

• Better use of existing data sources to analyze health IT-related safety incidents;
• Expanding access to data sources related to health IT in safety incidents through continued collaboration with private and public-sector stakeholders; and
• Increased transparency and communication about safety and health IT aimed to improve stakeholders' knowledge.

The HIMSS Electronic Health Record Association (EHRA)--made up of about 40 EHR vendors—submitted a letter to FDA Commissioner Margaret Hamburg expressing its support of the draft report.

The organization “supports the approach proposed in the draft report that categorizes health IT based on the level and nature of risk, then applying appropriate oversight mechanisms,” according to the letter. The EHRA has “promoted such an approach for some time.”

Despite its support, the EHRA called for inclusion of the following:

• A comprehensive framework for all health IT categories regardless of the agency or agencies tasked with oversight;
• Additional risks and controls for platform-specific technologies needed to ensure the framework is accessible across platforms; and
• Clear and more detailed risk category definitions.

The mHealth Regulatory Council said the issue calls for greater detail than what was included in the report which “doesn't go deep enough, specific enough, to get to the important issues.”

The Bipartisan Policy Center issued a press release that commended the draft report "for its inclusive and public approach towards the development of its proposed strategy and health IT regulatory framework and its inclusion of key principles and recommendations reflected in our report of last year."

The center also urged Congress to take appropriate action to support the draft report.

The Telecommunications Industry Association (TIA) offered its support for the framework in comments submitted to the FDA, praising the draft report for taking "notable steps towards providing clarity, and towards more clearly defining for stakeholders the role of different agencies."

The association, however, cautioned against an effort to categorize all health IT into three large categories. “Instead, TIA encourages a more flexible approach to products and devices, while also reflecting the overall service being delivered to the patient on the network or system level.”