Federal Regulations, Health IT and Patient Safety

Section 201 of the Federal Food, Drug, and Cosmetic Act, classifies medical devices in one of three classes, Class I, II, and III, with regulatory control increasing from Class I to Class III.

There has been a great deal of discussion this year about regulating electronic health records and other forms of health IT for patient safety. 

In late winter 2010, Dr. Jeffrey Shuren, the Director of the Food and Drug Administration’s Center for Device and Radiological Health, presented a possible road ahead for regulating EHRs.  His roadmap outlined three options, including:

1) Post-market Safety and Surveillance;

2) Quality Manufacturing Practices, adherence to FDA’s Quality System’s Regulation, and post-market safety and surveillance; and

3) traditional FDA pre-market regulation, which can take up to 180 days.

By Spring 2010, the Certification and Adoption Work Group of the Health IT Policy Committee presented a series of recommendations to the Committee that included a call for the a formal study by the Office of the National Coordinator to “ thoroughly evaluate HIT patient safety concerns, and to recommend additional actions and strategies to address those concerns.”

The Work Group had debated on whether the responsibility of information collection and database development should be handled by the federal government (FDA or ONC) or by a federally recognized independent Patient Safety Organization.   The complexity of the issue and lack of consensus on such questions as  who collects the data and for what purpose, will regulation hamper innovation or vendors’ ability to get products certified in a timely manner, and what is the impact on the Medicare and Medicaid EHR Incentive Programs forced the Work Group to recommend the formal study.

Since that time, the public comments from FDA and ONC have been limited to reassuring the healthcare community that they are working together to balance patient safety and innovation.

So, what do you think?

What should be the role of the federal government in ensuring the patient safety of health IT products and the settings in which they are utilized?

What are your suggestions for HIMSS as we attempt to foster a large scale dialogue on the issue?