The Stark Exception has aided in interoperability of the physician community by allowing health care entities to subsidize physician purchases of electronic health records (Electronic Health Record (EHR), as defined in Defining Key Health Information Technology Terms (The National Alliance for Health Information Technology, April 28, 2008): An electronic record of health-related information on an individual that conform... More ) items and services, while requiring that subsidized software be interoperable.
The Stark Exception was set to expire at the end of 2013, but on December 23 the government posted new final rules that extend the sunset date to December 31, 2021. This amendment allows health care entities to continue subsidizing physician purchases of EHRs.
Highlights of the rule extension include:
- Redefined interoperability
Clarification on limiting or restricting interoperability of subsidized items
- The donor cannot take action to limit the use, communication, or interoperability of the EHR by preventing other facilities from interfacing with it
- Nor can high fees be charged to other facilities for connectivity
- Complaints to limit interoperability in any way will be reviewed case-by-case
- Lab companies are now excluded from donating EHR items and services
- Removed e-prescribing requirements
Interoperability refers to the ability of two or more systems or components to exchange information and to use the information that has been exchanged. is now defined based on compliant EHR certification for Meaningful Use. On the date the EHR is provided to the physician, it must be a certified EHR technology listed on the Certified Health IT Product List managed by the Office of the National Coordinator for Health Information Technology (ONC) – Located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS), the Office of the National Coordinator (ONC) coordinates nationwide ... More .
At a minimum, this currently means that all subsidized EHRs moving forward will have the capability to support Direct Project  protocol. And based on the clarifications above, the donating entity cannot require the restriction or limitation of the use of Direct to send secure e-mails in any way.