The Office of the National Coordinator for Health IT (ONC) has released the ONC’s Cures Act Final Rule, which implements interoperability requirements outlined in the Cures Act.
 
The rule is designed to give patients and their healthcare providers secure access to health information, spur innovation, and address industry-wide information blocking practices.
 
With more access, patients gain more power in their health care, which enables the health care system to deliver the following:

  • Transparency into the cost and outcomes of their care.
  • Competitive options in getting medical care.
  • Modern smartphone apps to give patients convenient access to their records.
  • An app economy that provides patients, physicians, hospitals, payers, and employers with innovation and choice.

What the Rule Includes

A blog post by Elise Sweene Anthony, J.D. on HealthIT.gov outlines some provisions of the new rule. "The Cures Act Final Rule: Interoperability-Focused Policies that Empower Patients and Support Providers" says the rule includes the following measures: 

  • Sets in place new provisions for certified health IT developers who now will be required to establish a secure, standards-based API for use by providers and to support a patient’s access to core data in their electronic health record.
  • Supports the ability of patients to securely and easily obtain their electronic health information at no additional cost when electronically accessed, such as through a smartphone application.
  • Advances the needs of health care providers by accelerating innovation and competition, and will help deter the information blocking that many providers face when attempting to provide informed care for their patients.
  • Finalized eight common sense exceptions that are responsive to public comment and that identify reasonable and necessary activities that do not constitute information blocking.
  • Updates requirements for developers that participate in the ONC Health IT Certification Program, including the addition of provisions related to the ability of a health IT user to communicate regarding certain aspects of their health IT.
  • Adopts the U.S. Core Data for Interoperability (USCDI), which sets a new baseline for interoperability and includes “clinical notes” among other data important for clinical care. 

For more information, please read the full post.

For Health IT Developers

The new rule includes requirements for technology developers. “What the rule means for health IT developers” has additional details.
 
The act requires the Secretary of the U.S. Department of Health and Human Services to establish Conditions of Certification requirements for the ONC Health IT Certification Program.
 
The API Conditions of Certification address the use of APIs and the healthcare ecosystem in which APIs will be deployed, including health IT developers’ business practices. They only apply to actions and behaviors of certified health IT developers and their certified API technologies. See full requirements in the Conditions of Certification Requirements datasheet.
 
Certified health IT developers who previously certified their API to the certification criteria in the ONC rule have six months from the final rule’s effective date to meet these new API Conditions of Certification. They will need to provide customers with newly certified technology within 24 months of the rule’s effective date.
 
There are specific ongoing technical requirements for certified API developers about the process they may put in place to verify the authenticity of the API users and complete the registration of applications that use the newly certified API technology in a timely manner.