Transparency Requirements for Health IT Developers Will Help Providers Know More About Their Products
Elise Sweeney Anthony, J.D. and Steven Posnack, M.S., M.H.S. | June 1, 2016
Health information technology (health IT) developers must now comply with enhanced transparency requirements associated with their products. This regulatory requirement is applicable to all health IT certified to the 2014 Edition, as well as newly issued 2015 Edition of standards, implementation specifications, and certification criteria. These new disclosures are designed to help purchasers and users better understand the capabilities and limitations of their health IT products.
These requirements build on and are a major milestone in our efforts to make developers more accountable for the costs and performance of their health IT. Combined with improved access to product disclosure information posted on ONC’s new-look Certified Health IT Product List (CHPL) and newly-launched website, HealthIT.gov/transparency, these efforts improve the transparency associated with certified health IT.
The current health IT landscape has lacked reliable information about the costs, limitations, and trade-offs of competing health IT products and services. Without this information, health IT purchasers may find it hard to effectively understand and estimate the kinds of costs and implementation issues they may face. This lack of transparency also can limit incentives for developers to improve their products and can lead to practices— such as information blocking—that interfere with the flow of health information and the use of these tools to improve care.
Mandatory Disclosure Statements
Under the ONC Health IT Certification Program’s enhanced transparency requirements, developers must fully disclose all known material types of costs and limitations—including technical and contractual restrictions—that a user may encounter when implementing or using the developer’s technology. Developers must describe this information on their websites and in their marketing materials. These descriptions must use detailed, plain language that will allow providers and users to identify and understand the specific limitations and types of costs that may apply.
In addition to making mandatory product disclosures, developers must also submit a transparency attestation that states whether they will take additional, voluntary actions to promote transparency.
Nearly all developers who pledged to the three commitments to make electronic health records work better for patients and providers announced earlier this year attested that they will take these additional actions.
These voluntary actions include engaging in an open dialogue about their business practices and making such information available to potential customers and others in more targeted and useful ways. Developers who attest their support for transparency would be expected to provide any requestor with the information disclosed about their products and service offerings.
To verify that developers are reporting accurate and compliant disclosures, our ONC-Authorized Certification Bodies (ONC-ACB) are conducting ongoing surveillance of these new disclosure and transparency requirements. Developers whose disclosures do not meet the requirements will be subject to corrective action procedures and will be at risk of having their health IT’s certifications terminated. ONC-ACBs must also regularly report non-conformities and correction action plans on the CHPL, as well as details about the resolution for the non-conformity.
Accessing and Using Transparency Information
Developers’ product disclosures, transparency attestations, and other transparency-related information is now available on the CHPL and will also be regularly updated at healthIT.gov/transparency. This website provides a single place to access and compare health IT developers’ product disclosures and other transparency-related information.
In the coming months, we will be encouraging professional associations, product researchers, and other stakeholders to take advantage of developers’ product disclosures and transparency attestations, as well as the new functionality provided by the CHPL, to develop information and tools that providers can use to more effectively evaluate and compare health IT products.
These efforts are part of ONC’s ongoing commitment to making helpful information about certified health IT technology available and easily accessible to the providers who buy them, as outlined in the recent Report to Congress on the Feasibility of Mechanisms to Assist Providers in Comparing and Selecting Certified EHR Technology Products. More broadly, this transparency and accountability work is a vital part of creating the learning, person-centered health system outlined in the Federal Health IT Strategic Plan and the Shared Nationwide Interoperability Roadmap. In addition, ONC also recently issued challenge grants to spur the development of market-ready, user-friendly health apps for consumers and health care providers.