In response to a request for stakeholder input from Chairman Fred Upton of the House Energy and Commerce Committee, HIMSS joined the Bipartisan Policy Center and the Health It Now Coalition to submit feedback on the Sensible Oversight for Technology Which Advances Regulatory Efficiency Act of 2013 (SOFTWARE Act – HR 3303). Click the link to download the letter.
Letter to House Energy & Commerce Committee on the SOFTWARE Act
Dear Chairman Upton:
In response to your request for feedback on the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act of 2013, the undersigned organizations are pleased to submit our comments on an oversight framework for health information technology (IT) that improves patient safety, promotes innovation, and reduces regulatory duplication.
The contents of this letter are drawn from the work of the Bipartisan Policy Center (BPC), Health IT Now, and HIMSS—namely BPC’s report, An Oversight Framework for Assuring Patient Safety in Health Information Technology; Health IT Now’s letter to the FDASIA Work Group dated July 16, 2013 and its testimony to the Energy and Commerce Committee on March 20, 2013 and November 19, 2013; and HIMSS’ letter to the Department of Health and Human Services (HHS) Secretary dated November 6, 2013—along with a series of stakeholder meetings convened by BPC, Health IT Now, and HIMSS.
We believe Congress should update the statutory framework to provide clarity that clinical and administrative software should not be regulated as a medical device, a definition which Congress enacted more than forty years ago.
We support a flexible, risk-based oversight framework for clinical software to promote patient safety. To be effective, such a framework should:
- Recognize the important role that health IT plays in improving the quality, safety, and cost-effectiveness of care;
- Assure that patient safety is a shared responsibility that involves the entire health care system;
- Balance both costs and benefits;
- Ensure clear, consistent, and non-duplicative language and oversight;
- Be affordable to those expected to bear direct and indirect compliance costs; and
- Avoid adding burdens that inhibit or delay improvements to systems that improve care delivery and safety.