US Core Testing Guide
3.1.1-1 - ci-build United States of America flag

US Core Testing Guide - Local Development build (v3.1.1-1). See the Directory of published versions

Requirements: US Core 3.1.1 Requirements for US Core General Security Considerations

Official URL: http://hl7.org/fhir/us/core-tg/Requirements/us-core-req-security Version: 3.1.1-1
Draft as of 2023-08-25 Computable Name: USCoreReqSecurity

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:

* Communications
* Authentication
* Authorization/Access Control
* Audit Logging
* Digital Signatures
* Security Labels
* Narrative

These requirements reference http://hl7.org/fhir/us/core/STU3.1.1/security.html

These requirements apply to the following actors:

Statements

​us-core-req-security-01SHALL

Systems SHALL establish a risk analysis and management regime that conforms with HIPAA security regulatory requirements.

​us-core-req-security-01-aSHOULD

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 in accordance with 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.

Links:

​us-core-req-security-02SHALL

Systems SHALL reference a single time source to establish a common time base for security auditing, as well as clinical data records, among computing systems.

​us-core-req-security-02-aSHOULD

The selected time service SHOULD be documented in the Business Associate Agreement when available.

Links:

​us-core-req-security-03SHALL

Systems SHALL keep audit logs of the various transactions.

​us-core-req-security-04SHALL

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-core-req-security-04-aSHOULD

US Federal systems SHOULD conform with FIPS PUB 140-2.

Links:

​us-core-req-security-05SHALL

Systems SHALL conform to FHIR Communications Security requirements.

​us-core-req-security-06SHALL

For Authentication and Authorization, Systems SHALL support the SMART App Launch Framework for client <-> server interactions. NOTE: The SMART on FHIR specifications include the required OAuth 2.0 scopes for enabling security decisions.

​us-core-req-security-07SHALL

Systems SHALL implement consent requirements per their state, local, and institutional policies.

​us-core-req-security-07-aSHOULD

The Business Associate Agreements SHOULD document systems mutual consent requirements.

Links:

​us-core-req-security-08SHOULD

Systems SHOULD provide Provenance statements using the US Core Provenance Profile resource and associated requirements.

​us-core-req-security-09MAY

Systems MAY implement the FHIR Digital Signatures and provide feedback on its appropriateness for US Core transactions.

​us-core-req-security-10MAY

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.