The Office of the National Coordinator for Health Information Technology (ONC) hopes to have stronger oversight of health information technology (IT) by directly reviewing certified health IT products and testing bodies. The ONC’s Advance Release of the Proposed rule, scheduled for publication on March 2, 2016, would better allow the agency to ensure that health IT products are safe and meet the needs of providers and consumers by allowing more ONC input on products beginning in the testing phase and throughout implementation.
Direct review. The ONC wishes to directly review certified health IT in addition to and independent of the reviews conducted by ONC-Authorized Certification Bodies (ONC-ACBs). While ONC-ACBs certify health IT under established criteria, the ONC proposes to review the interaction of certified and uncertified capabilities within a product, as well as the interaction between products. The ONC intends that such reviews would focus on infrequent situations that pose a risk to health or safety, such as medical errors or health information breeches. The agency would have the ability to prescribe corrective actions such as investigating the reasons for non-conformities, notifying customers, and correcting identified issues. It would also be able to terminate certification. The rule states that such oversight would allow for a coordinated review and more consistent determinations.
Testing lab oversight. The ONC proposes to directly oversee testing labs. The agency currently requires ONC-ACBs to accept results only from accredited testing labs, but the ONC does not have oversight of the labs themselves. Under the rule, the labs would apply to become ONC-Authorized Testing Labs (ONC-ATLs) and the ONC would have the ability to authorize, retain, suspend, and revoke ONC-ATL status. The Proposed rule notes that health IT testing by accredited labs is the first opportunity to evaluate products, and establishing oversight of these labs will enable the agency to offer product input from the earliest stages.
Greater transparency and accountability. The rule would also require ONC-ACBs to publicly offer identifiable surveillance results each quarter in an effort to provide consumers with updates about health IT performance. The ONC believes that such action will both motivate developers to better maintain products and reassure health IT users that the products conform to established requirements.
Industry cooperation. The Proposed rule’s release coincides with HHS’ announcement of industry commitments to improve patient health care information access. Companies providing the bulk of electronic health record (EHR) technology to U.S. hospitals and large health care systems have pledged to implement the following:
- better consumer access;
- freely shared information when permitted by law; and
- national interoperability standards.
These commitments are a departure from current practices, where businesses can prevent patients from receiving their information or limit sharing between providers. Information sharing is also inhibited by technology that is difficult to use and that does not work well with other systems. Billions of dollars of subsidies have encouraged hospitals and offices to implement health IT and EHRs, but the goal of easier communication has not been entirely realized. By committing to stop purposeful “information blocking,” these organizations will be better able to treat patients and improve outcomes because they will have more comprehensive data.
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