The health information technology (HIT) systems of health plans, health care providers and government HIT vendors will be affected by the Department of Health and Human Services’ (DHHS) recent recognition as federal interoperability standards of six interoperability specifications adopted by the Healthcare Information Technology Standards Panel (HITSP). These six HITSP interoperability specifications became federal interoperability standards on January 16, 2009. See 74 Federal Register 3599 (Jan. 21, 2009).

Effect on EHR Donation. HIT systems will need to conform to the federal interoperability standards to qualify for the electronic health record (EHR) technology donation Anti-Kickback Statute safe harbor and Stark Law exception. DHHS explains that a certifying body, such as the Certification Commission for Healthcare Information Technology, must determine that EHR software is “in conformity with” these HITSP interoperability specifications “to be deemed interoperable” and “eligible for donation to certain health care providers” under the Anti-Kickback Statute safe harbor and the Stark Law exception.

Action Item: Health plans, hospitals and other donors of EHR technology to physicians and other health care providers need to ensure that the EHR software they subsidize meets these HITSP interoperability specifications.

Effect on Federal Health Care Program Contractors. Executive Order 13410 (Aug. 22, 2006) directs that the contracts of the federal agencies that administer or sponsor federal health care programs require health plans and health care providers to meet federal interoperability standards as the health plans and providers acquire, implement or upgrade HIT systems. The federal agencies and federal health care programs affected by Executive Order 13410 are the Centers for Medicare and Medicaid Services for Medicare, the Department of Defense for TRICARE, the Indian Health Service for Native American health, the Department of Veterans Affairs for veteran’s health, and the Office of Personnel Management for the Federal Employees Health Benefit Program.

Action Item: Health plans and health care providers need to examine their contracts with these federal agencies to determine if the contracts will require them to meet these HITSP interoperability specifications when they acquire, implement or upgrade their HIT systems.

Effect on Federal Agencies. Executive Order 13410 also directs these federal agencies to require that the HIT systems they acquire, implement or upgrade, which will be used for the direct exchange of health information with other federal agencies or with non-federal entities (such as health plans and health care providers), meet federal interoperability standards.

Action Item: HIT vendors need to ensure that the HIT systems they develop, maintain or upgrade for these federal agencies will meet these HITSP interoperability specifications.

The HITSP Interoperability Specifications. The six HITSP interoperability specifications that DHHS has recognized as federal interoperability standards are:

  • IS01: Electronic Health Records Laboratory Results Reporting (ver. 3)—interoperability specifications to support electronic communication between EHRs and laboratory IT systems
  • IS02: Biosurveillance (ver. 3)—interoperability specifications to promote the electronic exchange of biosurveillance information between and among health care providers and public health authorities
  • IS03: Consumer Empowerment and Access to Clinical Information via Networks (ver. 3)—interoperability specifications to assist patients in making decisions regarding care and healthy lifestyles and to enable the electronic exchange of data between patients and their caregivers via IT networks
  • IS04: Emergency Responder Electronic Health Record (ver. 1)—interoperability specifications to track and electronically exchange with on-site emergency care professionals, medical examiners and public health practitioners needed information regarding care, treatment or investigation of emergency incident victims
  • IS05: Consumer Empowerment and Access to Clinical Information via Media (ver. 1)—interoperability specifications to assist patients in making decisions regarding care and healthy lifestyles and to enable the electronic exchange of data between patients and their caregivers via physical media or secure email
  • IS06: Quality (ver. 1)—interoperability specifications to benefit providers and clinicians by furnishing electronically data for inpatient and ambulatory care and real-time or near real-time feedback regarding quality indicators for specific patients

The details underlying each of these six HITSP interoperability specifications are available on the HITSP web site at http://www.hitsp.org/.