Providers, Employers, Patient Groups Want Laws to Boost Innovation

A group of 58 providers, employers, and patient groups asked Congress in a letter to provide clarity and certainty for appropriate, risk-based oversight of health information technology (IT). The letter comes in response to recommendations provided on appropriate risk-based framework under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 (P.L. 112-144), stating, “[i]t is now time for lawmakers to pass legislation that achieves the complementary goals of protecting patients, ensuring safe and effective care, and fostering continued innovation in the rapidly-growing health IT field.”

Risk-Based Regulatory Framework

Together with the Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC), the FDA set up a working group to gather input from stakeholders and experts to inform the FDA on appropriate, risk-based regulatory framework for health IT. The agencies released a proposed strategy and recommendations for a risk-based framework in April 2014. The letter urges lawmakers to solidify these recommendations with legislation and lists the following as the main reasons that the Senate and House of Representatives should act before the end of the 113th Congress:

  • The potential for health IT to improve the efficiency and quality of care, including patients and caregivers using information software to integrate disease management and wellness activities into their daily routines, increasing adherence to care plans, and reducing preventable hospitalization;
  • Current regulatory uncertainty that stifles health care innovation, creating barriers to development of promising technologies “that can help clinicians access more evidence-based medicine, provide patient populations with specific needs more individualized care, and generate better patient-caregiver-provider engagement;
  • Broad consensus that (1) there are three categories of health IT; (2) FDA regulation should focus on the category of technologies presenting the highest risk to the safety of patients; (3) the category of technologies presenting no risk to patient safety should not be regulated; and (4) the third category, which poses some risk, should be subject to risk-based oversight using consensus standards and private certification bodies to verify the function of health IT technologies; and
  • The bipartisan nature of the issue, which is “ready for bipartisan action.”

In support of the multi-group letter, Joel White, Health IT Now Coalition executive director, said, “It is time for modern laws to reflect the technological advancements made in our healthcare system over the past four decades. Developers, healthcare providers, patients and others still face ambiguity on the framework for health IT oversight. Without a clearly defined, risk-based oversight framework, we cannot effectively facilitate innovation in the use of technologies to improve health, protect patients and enhance clinical safety.”