The AAMC June 3 submitted comments to the Office of the National Coordinator for Health Information Technology (ONC) and comments to the Centers for Medicare and Medicaid Services(CMS) in response to proposed rules released earlier this year to implement the 21st Century Cures Act and improve electronic health record interoperability [see Washington Highlights, April 19].
The AAMC supports efforts to advance interoperability and the access, exchange, and use of electronic health information and prevention of information blocking. Efforts to improve interoperability should focus on what is needed for high-quality clinical management of patients receiving care from providers as they move through the health care system, while also protecting the privacy and security of patient health information.
The AAMC’s comments on the ONC proposals include:
- Implementation Time Frames: The ONC must provide sufficient time for “actors” to comply with the information blocking provisions, for vendors to comply with the new certification criteria, and for providers to deploy the updates to the systems. The ONC and CMS should coordinate to allow, at the very least, additional implementation time beyond the 24 months proposed in the rule.
- Definition of Electronic Health Information (EHI):The proposed EHI definition that would apply to information blocking is overly expansive and should be revised to include only the USCDI data elements stored within the electronic health record (EHR). Payment information should not be included in the definition of EHI. Nonobservational information should not be included within the definition of EHI as such information is not necessary for direct patient care and its inclusion could potentially deter reporting of adverse events and quality improvement initiatives.
- Standardizing Application Program Interfaces (APIs): The ONC should set forth requirements related to standardization and transparency associated with APIs, while also ensuring protections are in place to promote the privacy and security of EHI.
- Permitted Fees: The ONC should reconsider its proposals related to permitted fees, as they are likely to place significant financial burden on the API data providers. The ONC should consider balancing the costs associated for API development and deployment across both API data providers and certain API users, to ensure that third-party software application developers are contributing.
- Innocuous and Beneficial Activities Should Not be Considered Information Blocking: The AAMC supports efforts to deter practices that unnecessarily impede the flow of EHI or its use to improve health and the delivery of care. We believe it is important that activities that are innocuous and beneficial are not considered violations of the information blocking provision.
- Clear, Predictable, and Feasible to Implement: To minimize burden for providers, the information blocking provisions and exceptions need to be clear, predictable, and feasible to implement, and sensitive to practical challenges that may prevent access, exchange, or use of EHI.
- Information Blocking Exception: Information blocking rules must be aligned with HIPAA privacy and state privacy laws to the extent possible. Providers should not be compelled to share EHI against a patient’s wishes or without adequate safeguards.
- Collaboration on Patient Matching Solutions: Providers, software developers, and other health care organizations should collaborate on the identification of a common set of data elements based on federal adopted standards to support patient matching. HHS should participate and provide technical assistance to the private sector in developing standards for patient matching.
The AAMC’s comments specific to the CMS proposed rule include:
Conditions of Participation Requirements to Send Admission, Discharge, or Transfer Notifications: Given the immaturity of the infrastructure of interoperability, unanswered questions, and significant implementation issues, the conditions of participation should not be used as the mechanism to ensure hospitals provide the admission, discharge, and transfer electronic notifications. CMS should consider other approaches to encourage these notifications, such as setting forth requirements related to the exchange of this information in the Promoting Interoperability Program.
Patient Information in Apps: EHR API vendors that are certified by ONC should certify that apps that connect via their APIs meet established best practices and privacy guidelines and provide a model notice to patients regarding how their information might be used by the app.
Information Blocking and Public Reporting: CMS should ensure hospitals and physicians have the opportunity to make corrections if data is inaccurate and would erroneously publicly report the hospital or physician as an information blocker. During this time of great transition to interoperability, public reporting should not be used until there is stability in the transformation.