HIPAA Security Rule 2003
Active
Best for: A covered entity or business associate must comply with the applicable standards, implementation specifications, and requirements of the Security Rule with respect to electronic protected health information. It applies to healthcare providers, health plans, and healthcare clearinghouses.
| Mandatory? | Mandatory for covered entities and business associates |
|---|---|
| Who validates? | No formal certification; HHS/OCR enforcement |
| Renewal | No fixed cycle; periodic risk assessments required |
| Scope | Electronic protected health information (ePHI) |
Controls by category
115 controls are Mapped to HIPAA Security Rule 2003.
164.308(a)(1)(ii)(A) Risk analysis
164.308(a)(1)(ii)(B) Risk Management
164.308(a)(1)(ii)(D) Information system activity review
164.308(a)(3)(i) Workforce security
164.308(a)(3)(ii)(A) Authorization and/or supervision
164.308(a)(3)(ii)(B) Workforce clearance procedure
164.308(a)(4)(i) Information access management
164.308(a)(4)(ii)(A) Isolating health care clearinghouse functions
164.308(a)(4)(ii)(B) Access authorization
164.308(a)(4)(ii)(C) Access establishment and modification
164.308(a)(5)(ii)(B) Protection from malicious software
164.308(a)(5)(ii)(C) Log-in monitoring
164.308(a)(5)(ii)(D) Password management
164.308(a)(6)(i) Security incident procedures
164.308(a)(6)(ii) Response and reporting
164.308(a)(7)(i) Contingency plan
164.308(a)(7)(ii)(A) Data backup plan
164.308(a)(7)(ii)(B) Disaster recovery plan
164.308(a)(7)(ii)(C) Emergency mode operation plan
164.308(a)(8) Evaluation
164.310(a)(1) Facility access controls
164.310(d)(1) Device and media controls
164.312(a)(1) Access control
164.312(a)(2)(i) Unique user identification
164.312(a)(2)(ii) Emergency access procedure
164.312(a)(2)(iv) Encryption and decryption
164.312(b) Audit controls
164.312(c)(1) Integrity
164.312(c)(2) Mechanism to authenticate electronic protected health information
164.312(d) Person or entity authentication
164.312(e)(1) Transmission security
164.312(e)(2)(i) Integrity controls
164.312(e)(2)(ii) Encryption
Related frameworks
| Framework | Control overlap | Note |
|---|---|---|
| NIS2 Directive (EU 2022/2555) | High 84% | |
| BSI C5:2025 | High 82% | |
| RBI Cyber Security Framework for UCBs | High 81% |
Frequently asked questions
Who must comply with the HIPAA Security Rule?
A covered entity or business associate must comply with the applicable standards, implementation specifications, and requirements of `Subpart C` with respect to the electronic protected health information of a covered entity.
What is the difference between required and addressable implementation specifications?
A required specification must be implemented. For an addressable one, the entity assesses whether it is reasonable and appropriate. If it is, the entity implements it. If not, the entity documents why not and implements an equivalent alternative measure if reasonable and appropriate.
Does a HIPAA certification program exist for cloud providers?
There is currently no certification program approved by the US Department of Health and Human Services through which a cloud service provider acting as a business associate could demonstrate compliance with HIPAA and the HITECH Act.
Does using Azure make a cloud solution HIPAA compliant?
Using Azure does not automatically impart compliance onto your cloud solutions. Your organization is responsible for an adequate compliance program and internal processes, and for ensuring that your use of Azure aligns with HIPAA and the HITECH Act.