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HHS announces stricter transparency requirements on health IT developers
HHS announced a series of new requirements for information technology developers serving the health sector aimed at increasing transparency and making it easier to find reliable information about the costs and limitations of various products and services.
Under the new requirements, developed under the HHS Office of the National Coordinator for Health Information Technology (ONC), information technology (IT) developers must fully disclose all known material costs and limitations, including technical and contractual restrictions, involved in a product or service. IT developers must also submit a “transparency attestation,” stating whether they plan to take additional, voluntary steps to increase transparency.
In addition, all of this information will be posted on the ONC’s Certified Health IT Product List (CHPL) and a new government website, which can be found at HealthIT.gov/transparency. Developers must also publish the mandatory disclosure statements on their own websites and marketing materials, in “detailed, plain language.”
“These new efforts to provide more and easier-to-understand information are critical to helping clinicians find the right tools to provide better care and improve the health of their patients,” Karen DeSalvo, MD, MPH, MSc, the HHS national coordinator for health IT, said in a press release. “This information and our new websites will make the process of comparing and buying certified health IT simpler and better, discourage information blocking, and create clear incentives for developers to focus on the quality and usability of their products.
The new transparency requirements are mandated under the ONC 2015 Edition final rule, and apply to all health IT certified to the 2014 Edition and 2015 Edition of standards, implementation specifications and certification criteria.
According to an HHS statement released Wednesday, the previous status quo regarding health IT had “lacked reliable information about costs, limitations and trade-offs” of competing products and services. This made it more likely for clinicians to suddenly face unexpected costs, implementation issues and information blocking.
The new regulations also allow ONC-authorized certification bodies to conduct ongoing surveillance on certified IT products, and take corrective action against developers who do not meet the requirements. According to HHS, those found in delinquency will be at risk of losing their health IT certifications. ONC bodies must report violations and corrective action plans, as well as the eventual resolution of the issue, on the CHPL.
The new rules are part of a larger ONC effort to improve health IT for clinicians, and follow an April report issued by the office to Congress, that outlined ways to improve the health IT market.
According to HHS, 65% of developers who have certified health IT products have pledged their commitment to more transparency.
“I am thrilled that so many of our partners in the health IT developer community have reiterated their commitment to the work we are doing together to ensure that electronic health data flows seamlessly and securely where and when it is needed,” De Salvo said.
Additional reading:
https://www.healthit.gov/sites/default/files/macraehrpct_final_4-2016.pdf