Stakeholders Tell Congress To Pass HIT Legislation
By Christine Kern, contributing writer
A slew of healthcare players send a letter to Congress urging lawmakers to provide clarity and certainty for the oversight of health information technology.
In the latest attempt to push for what they consider to be crucial legislation that regulates health information technology, a group of 58 stakeholders sent a strongly worded letter to Congress. The letter urges lawmakers to pass legislation before the end of the year to “provide clarity and certainty for appropriate, risk-based oversight of health information technology.”
As Health IT Outcomes reported, earlier this year, the FDA, ONC Coordinator for HIT, and the FCC created and released a risk-based regulatory framework for health IT. The framework was designed using input from stakeholders and experts, and was designed to promote innovation, protect patient safety, and avoid regulatory duplication. Despite criticism, the FDA said that the framework was a turning point in establishing a new regulatory paradigm.
The stakeholder’s letter states, “The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 called upon the Administration to provide recommendations to Congress on an appropriate risk-based framework. With the release of the recommendations in April, it 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.”
The stakeholders also argued that Congress must take action now, before the end of this year’s session, in order to “clarify the lines of regulatory jurisdiction by updating the law under which health IT is currently regulated.” Such long overdue action would “allow the Administration to focus its limited resources, staff, and expertise on ensuring the safety of new medical technologies that pose the highest potential risk to patients, and will promote a new era of medical innovation that will improve care and lower costs.”
After the release of the proposed framework in May, Joel White, executive director of the Health IT Now Coalition, responded in a statement, saying, “The report’s recommendations highlight the importance of congressional action to clarify the law as to how health IT products are, in fact, regulated. Developers, healthcare providers, patients, and others still face ambiguity, which is why it is imperative that Congress update the regulatory framework for health IT – a product of the 1970s – in order to facilitate innovation in use of technologies to improve health.
Among the 58 stakeholders that signed the letter were AMIA, athenahealth, the Institute for eHealth Policy, Health IT Now, the National Alliance on Mental Illness, the U. S. Chamber of Commerce, and WellDoc, Inc.