Healthcare Regulations

Regulatory compliance guides for HIPAA, HITECH, and healthcare privacy laws

Section
regulation
Type
overview
Audience
mixed
US
CMS
interoperability

CMS Interoperability Rules Overview

Reference for CMS interoperability mandates: CMS-9115-F (2020), CMS-0057-F (2024), covered entities, data exchange APIs, compliance timelines, and penalties.

Section
regulation
Type
overview
Audience
mixed
AU
OAIC ADHA
privacy

Australian Privacy Act and Health Data

Reference overview of the Privacy Act 1988, state health records laws, My Health Record Act, and notifiable data breaches obligations for health data in Australia.

Section
regulation
Type
overview
Audience
mixed
US
CMS
interoperability

Provider Access API (CMS-0057-F)

Reference for the CMS-0057-F Provider Access API obligation: payers sharing patient data with treating providers, PDex IG, member match, data scope, January 2027 compliance, and implementation requirements.

Section
regulation
Type
overview
Audience
mixed
global
Te Whatu Ora OPC
privacy

New Zealand Digital Health Standards

Reference overview of NZ digital health standards: Privacy Act 2020, Health Information Privacy Code, Te Whatu Ora, NHI, FHIR NZ Base profiles, NZePS, and the NZ Health Terminology Service.

Section
regulation
Type
overview
Audience
mixed
US
ONC OIG
interoperability

Information Blocking Rule (ONC)

Reference for ONC's Information Blocking Rule under 21st Century Cures Act: definition, actors, eight exceptions, penalties, and enforcement mechanisms.

Section
regulation
Type
overview
Audience
technical
UK
NHS England DHSC
interoperability

NHS England Digital Standards

Reference overview of NHS England digital and data standards for suppliers: DSPT, NHS number and PDS, Care Identity Service, NHS login, NHS England FHIR APIs, and supplier onboarding obligations.

Section
regulation
Type
overview
Audience
mixed
US
ONC
interoperability

TEFCA — Trusted Exchange Framework and Common Agreement

Reference for TEFCA: the ONC framework for nationwide health information exchange, Qualified Health Information Networks (QHINs), the Common Agreement, exchange purposes, and participation model.

Section
regulation
Type
overview
Audience
technical
AU
ADHA Services Australia
interoperability

Australian Digital Health Standards

Reference overview of Australian digital health technical standards: ADHA, AU Base FHIR profiles, My Health Record FHIR API, NCTS, AMT, IHI/HPI identifiers, and NASH PKI.

Section
regulation
Type
overview
Audience
mixed
US
CMS
interoperability

Patient Access API (CMS-9115-F)

Reference for the CMS-9115-F Patient Access API: FHIR-based patient data access, CARIN Blue Button, US Core, SMART App Launch, scope of required data, and compliance timelines.

Section
regulation
Type
overview
Audience
mixed
US
HHS
privacy

HIPAA

Reference overview of HIPAA Privacy and Security concepts for health IT builders: safeguards, minimum necessary, auditability, and common engineering considerations.

Section
regulation
Type
overview
Audience
mixed
US
ONC
interoperability

ONC 21st Century Cures Act Final Rule

Reference for the ONC 21st Century Cures Act Final Rule: FHIR API certification requirements, USCDI, information blocking prohibition, health IT certification criteria, and implementation timelines.

Section
regulation
Type
overview
Audience
mixed
UK
ICO DHSC
privacy

UK GDPR and Health Data

Reference overview of UK GDPR and DPA 2018 obligations for health data: special category conditions, controller/processor model, data subject rights, DPIA triggers, and ICO enforcement.

Section
regulation
Type
compliance-guide
Audience
technical
UK
NHS England
interoperability

UK Core FHIR Profiles

Reference for UK Core: NHS England's national FHIR R4 profile set, UK-specific extensions, relationship to Care Connect, dm+d for medications, and conformance for NHS Digital API access.