HHS on March 11 published a summary highlighting the changes made from its proposed interoperability rules to the final regulations, which were posted earlier this week.
The rule, issued by ONC last February, requires the health IT industry to adopt standard application programming interfaces to help patients more easily access their health data from smartphone apps. The regulations also limit information blocking practices and boost the sharing of health records data by approving methods such as screenshots and video to communicate about health IT.
Here are 10 things to know about the changes from the proposed rule to the final rule:
1. Health IT vendors will have 36 months to release single patients' electronic health information as well as exporting all patient data when a healthcare provider switches EHR systems.
2. Fast Healthcare Interoperability Resources Release 4 was adopted for the final rule rather than the previously proposed HL7 FHIR standard.
3. Health IT vendors are prohibited to restrict the sharing of screenshots and videos of their software; however, they can limit the number of screenshots and video of their products to protect their intellectual property.
4. Healthcare providers, health IT developers, health information exchanges and health information networks — collectively referred to as "actors" — have until six months after the final rule is published to comply with the information blocking provision. Timelines for assessing civil monetary penalties will be determined later.
5. While the proposed rule offers a broad definition for EHI, the final rule refers to it as the record set designated by HIPAA. EHI for purposes of the information blocking definition will be limited to the EHI identified by data elements referred to in the USCDI standard.
6. The final rule clarifies definitions of "access," "exchange" and "use." Use refers to the ability for EHI, once accessed or exchanged, to be understood and acted upon. The term "transmitted" was also clarified as not being limited to a one-way transmission, but instead includes all transmissions of EHI.
7. It will not be considered information blocking, or an interference with the access, exchange or use of EHI, to notify patients that the apps they choose may or may not follow best privacy policies and practices.
8. The final rule finalized eight information blocking exceptions, which are broken down into two categories: exceptions involving not completing requests to access, exchange or use EHI; and exceptions involving procedures for completing requests to access, exchange or use EHI.
9. Actors can require third-party apps to provide patient consent or authorization before giving them access to EHI, but they must offer a consent form in a reasonable time and manner.
10. Actors may charge fees, including those that result in a reasonable profit margin, for accessing, exchanging or using EHI.
Click here to view the full report of ONC's changes and clarifications to the final rule.