Coalition Urges Congress To Act on Health IT Regulatory Policies

October 8, 2014 in News

On Tuesday, a coalition of industry stakeholders sent a letter to federal lawmakers urging them to take action on a risk-based regulatory framework for health IT released earlier this year, Health Data Management reports (Slabodkin, Health Data Management, 10/8).


In April, HHS released a draft report that included a proposed strategy and recommendations for creating a risk-based health IT regulatory framework, as required by the Food and Drug Administration Safety and Innovation Act. The proposal was developed by FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission.

Under the federal agencies’ proposal, health IT products would be classified into three categories based on the function and risk level of the product, rather than on the product’s platform.

The first category would include health IT products with administrative functions that pose little or no risk to patient safety and therefore require no additional oversight. Products in this category would include software for billing, claims processing, scheduling and inventory management.

The second category would include health IT products with health management functions, such as software for health information management, medication management, provider order entry and most clinical decision support. Because such products are of relatively low risk, FDA does not plan to focus its oversight on them. Instead, the draft report recommends relying on ONC and private-sector efforts to highlight quality management, industry standards and best practices. The draft report also proposes incorporating testing, certification and accreditation processes for products in this category.

The third category would include health IT products with medical device functions that could potentially pose significant risks to patients if they do not perform as intended. Such products would include computer-aided detection software, software for bedside monitor alarms and radiation treatment software. According to the draft report, FDA would continue to regulate health IT products that fall in this category.

The proposed framework also calls for ONC to work with FDA, FCC, the Agency for Healthcare Research and Quality and other stakeholders to create a public-private Health IT Safety Center. The center would be tasked with developing best practices and providing an avenue for sharing information and ideas related to patient safety (iHealthBeat, 4/3).

Letter Details

The letter was written by a group of 58 patient groups, providers and health IT vendors, including

  • athenahealth;
  • Health IT Now;
  • IBM;
  • National Alliance on Mental Illness;
  • Pharmacy HIT Collaborative; and
  • U.S. Chamber of Commerce (Coalition letter, 10/7).

In the letter, the groups urged Congress to take legislative action on the proposal before the end of the Legislative session to “provide clarity and certainty for appropriate, risk-based oversight of health [IT]” (Health Data Management, 10/8).

Specifically, the groups argued that the House and Senate must act soon because:

  • Current uncertainties over regulations curb health care innovation;
  • Health IT could significantly improve the quality and efficiency of care delivery;
  • Many stakeholders agree that there is a need for such a regulatory framework; and
  • The issue is bipartisan (Health IT Now Coalition release, 10/7).

mHealth Regulatory Coalition General Counsel Argues Against Action

Meanwhile, mHealth Regulatory Coalition General Counsel Bradley Merrill Thompson argued against Congressional action, saying that FDA should be able to regulate health IT without changing existing laws that could eventually harm the industry.

He said, “Rushing to do something is a recipe for bad policy. If Congress acts precipitously, it can cause more harm than good, and bring more confusion than clarity.” He added that although the group “fundamentally” agrees that “government regulation needs to be as clear as possible” for the industry, it is instead “urging FDA to publish guidance documents that really clarify at a granular level what gets regulated versus what doesn’t” (Health Data Management, 10/8).

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