US Core Implementation Guide
7.0.0-ballot - Ballot United States of America flag

This page is part of the US Core (v7.0.0-ballot: STU7 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 6.1.0. For a full list of available versions, see the Directory of published versions

Security

Page standards status: Informative

Patient Privacy and Security

US Core transactions often use patient-specific information, which could be exploited by malicious actors resulting in the exposure of patient data. For this reason, all US Core transactions must be secured appropriately with access to limited authorized individuals, data protected in transit, and appropriate audit measures taken.

Implementers SHOULD be aware of these security considerations associated with FHIR transactions, particularly those related to:

For US Core, security conformance requirements are as follows:

  • Systems SHALL establish a risk analysis and management regime that conforms with HIPAA security regulatory requirements. In addition, US Federal systems SHOULD conform with the risk management and mitigation requirements defined in NIST 800 series documents. This SHOULD include security category assignment following NIST 800-60 vol. 2 Appendix D.14. The coordination of risk management and the related security and privacy controls – policies, administrative practices, and technical controls – SHOULD be defined in the Business Associate Agreement when available.
  • Systems SHALL reference a single time source to establish a common time base for security auditing and clinical data records among computing systems. The selected time service SHOULD be documented in the Business Associate Agreement when available.
  • Systems SHALL keep audit logs of the various transactions.
  • Systems SHALL use TLS version 1.2 or higher for all transmissions not taking place over a secure network connection. (Using TLS even within a secured network environment is still encouraged to provide defense in depth.) US Federal systems SHOULD conform with FIPS PUB 140-2.
  • Systems SHALL conform to FHIR Communications Security requirements.
  • For Authentication and Authorization, Systems SHALL support any SMART App Launch version for client <-> server interactions. NOTE: The SMART App Launch specifications include the required OAuth 2.0 scopes for enabling security decisions.
  • Systems SHALL implement consent requirements per their state, local, and institutional policies. The Business Associate Agreements SHOULD document systems’ mutual consent requirements.
  • Systems SHOULD provide Provenance statements using the US Core Provenance Profile resource and associated requirements.
  • Systems MAY implement the FHIR Digital Signatures and provide feedback on its appropriateness for US Core transactions.
  • Systems MAY protect the confidentiality of data at rest via encryption and associated access controls. The policies and methods used are outside the scope of this specification.

Clinical Safety

When implementing FHIR and US Core, implementers need to be aware of the risks and tradeoffs and are encouraged to review the clinical safety section in the core specification.