Life Science Compliance Update

« Previous article | Home| Next article »

March 16, 2016

Office of the National Coordinator for Health Information Technology Proposes Rule on Information Blocking

The United States Department of Health and Human Services released a proposed rule last week that would permit the Office of the National Coordinator for Health Information Technology (ONC) to review certified health IT products for information blocking, in addition to potential risks to patient safety and public health. The proposed rule also gives ONC increased power to regulate authorized certification-testing bodies.

Background

The ONC Health IT Certification Program was established as a Temporary Certification Program in June 2010, and was later transitioned into a Permanent Certification Program in January 2011. In September 2012, certification criteria were established to provide a clear implementation direction to ONC-Authorized Certification Bodies for certifying Health IT Modules.

In October 2015, HHS published a final rule that identified how health IT certification can support the establishment of an interoperable nationwide health information infrastructure through the certification and use of adopted new and updated vocabulary and content standards for structured recording and exchange of health information. This final rule also included provisions to increase the transparency of information related to health IT certified under the program.

The impetus behind this proposed rule is that as certified capabilities interact with other capabilities in certified health IT and with other products, it is important to ensure that concerns within the scope of the Program can be appropriately addressed.

The Health Information Technology for Economic and Clinical Health (HITECH) Act amended the Public Health Service Act (PHSA) in an attempt to improve the quality, safety, and efficiency of health care through the promotion of health IT and electronic health information exchange. The HITECH Act also required the National Coordinator for Health Information Technology perform specific statutory duties, including keeping or recognizing a program for the voluntary certification of health information technology.

This proposed rule proposes to expand the ONC's role in the Program to encompass the ability to directly review health IT certified under the Program and address non-conformities found in certified Health IT, as well as propose processes for ONC to timely and directly address testing issues. According to the drafters of the Rule, increased transparency and publication of identifiable surveillance results would support further accountability of health IT developers to their customers and users of certified health IT.

The Proposed Rule

The proposed rule asks to expand the ONC's role to encompass the ability to directly review health IT certified under the Program, independently of reviews conducted by ONC-ACBs. These reviews would extend beyond the continued conformance of the certified health IT's capabilities with specific certification criteria, test procedures, and certification requirements and would also extend to the interaction of certified and uncertified capabilities within the certified health IT.

ONC would also have broad discretion to review certified health, though the drafters of the rule anticipate that such a review would be relatively infrequent and would focus on situations that pose a risk to public health or safety.

The proposed rule also gives authority to ONC to initiate a direct review whenever it becomes aware of information, whether from the general public, interested stakeholders, ONC'ACBs, or by any other means, that certified health IT may not conform to the requirements of its certification.

The rule also proposes to require ONC-ACBs to make identifiable surveillance results publicly available on their websites on a quarterly basis. The rule drafters believe that by publishing "positive" surveillance results, as well as "negative" ones, will provide a more complete context of surveillance.

Analysis and Conclusion

According to Sherilyn Pruitt, director of ONC's Office of Programs and Engagement, "our goal is to work with developers. Our goal is not to get to decertification." Ms. Pruitt expects the office to work with noncompliant vendors to develop action plans to fix their products and practices.

The proposed rule follows announcements by dozens of health IT vendors, major health systems, and other industry organizations, that they will provide wider consumer access to health data, avoid information blocking, and adopt federally recognized interoperability standards. In announcing the interoperability pledge, HHS Secretary Sylvia Mathews Burwell stated, "we must demand interoperability. We have to work together to unblock data."

The proposed rule also comes after the Precision Medicine Initiative Summit at the White House, where data liquidity was in focus. According to national health IT coordinator Dr. Karen DeSalvo, "the president of the United States has a keen interest in seeing that data moves. We would like to see change [to interoperability] as rapidly as possible, but as safely and securely as possible."

Comments will be accepted on the proposed rule through May 2, 2016, and can be submitted via the Federal eRulemaking Portal or the mail.

« Previous article | Home| Next article »

Comments

Feed You can follow this conversation by subscribing to the comment feed for this post.

The comments to this entry are closed.

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
September 2017
Sun Mon Tue Wed Thu Fri Sat
1 2
3 4 5 6 7 8 9
10 11 12 13 14 15 16
17 18 19 20 21 22 23
24 25 26 27 28 29 30