HIPAA Compliance

To download the 2021 Attestation Letter for the HIPAA/HITECH Security Risk Assessment, click here.

This is a summary of key elements of the Security Rule including who is covered, what information is protected, and what safeguards must be in place to ensure appropriate protection of electronic protected health information.  Because it is an overview of the Security Rule, it does not address every detail of each provision.

Statutory and Regulatory Background

• The Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) required the Secretary of HHS to publish national standards for the security of electronic protected health information (e-PHI), electronic exchange, and the privacy and security of health information.

HIPAA called on the Secretary to issue security regulations regarding measures for protecting the integrity, confidentiality, and availability of e-PHI that is held or transmitted by covered entities. HHS developed a proposed rule and released it for public comment on August 12, 1998. The Department received approximately 2,350 public comments. The final regulation, the Security Rule, was published February 20, 2003.2 The Rule specifies a series of administrative, technical, and physical security procedures for covered entities to use to assure the confidentiality, integrity, and availability of e-PHI. The text of the final regulation can be found at 45 CFR Part 160 and Part 164, Subparts A and C.

Who is Covered by the Security Rule

• The Security Rule applies to health plans, health care clearinghouses, and to any health care provider who transmits health information in electronic form in connection with a transaction for which the Secretary of HHS has adopted standards under HIPAA (the “covered entities”) and to their business associates. For help in determining whether you are covered, use CMS’s decision tool.

Read more about covered entities in the Summary of the HIPAA Privacy Rule – PDF – PDF.

Business Associates

• The HITECH Act of 2009 expanded the responsibilities of business associates under the HIPAA Security Rule. HHS developed regulations to implement and clarify these changes.

See additional guidance on business associates.

What Information is Protected

• Electronic Protected Health Information. The HIPAA Privacy Rule protects the privacy of individually identifiable health information, called protected health information (PHI), as explained in the Privacy Rule and here – PDF – PDF. The Security Rule protects a subset of information covered by the Privacy Rule, which is all individually identifiable health information a covered entity creates, receives, maintains or transmits in electronic form. The Security Rule calls this information “electronic protected health information” (e-PHI).3 The Security Rule does not apply to PHI transmitted orally or in writing.

General Rules

• The Security Rule requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards for protecting e-PHI.

Specifically, covered entities must:

1. Ensure the confidentiality, integrity, and availability of all e-PHI they create, receive, maintain or transmit;
2. Identify and protect against reasonably anticipated threats to the security or integrity of the information;
3. Protect against reasonably anticipated, impermissible uses or disclosures; and
4. Ensure compliance by their workforce.4 The Security Rule defines “confidentiality” to mean that e-PHI is not available or disclosed to unauthorized persons. The Security Rule’s confidentiality requirements support the Privacy Rule’s prohibitions against improper uses and disclosures of PHI. The Security rule also promotes the two additional goals of maintaining the integrity and availability of e-PHI. Under the Security Rule, “integrity” means that e-PHI is not altered or destroyed in an unauthorized manner. “Availability” means that e-PHI is accessible and usable on demand by an authorized person.5

HHS recognizes that covered entities range from the smallest provider to the largest, multi-state health plan. Therefore the Security Rule is flexible and scalable to allow covered entities to analyze their own needs and implement solutions appropriate for their specific environments. What is appropriate for a particular covered entity will depend on the nature of the covered entity’s business, as well as the covered entity’s size and resources. Therefore, when a covered entity is deciding which security measures to use, the Rule does not dictate those measures but requires the covered entity to consider:

• • Its size, complexity, and capabilities,
  • Its technical, hardware, and software infrastructure,
  • The costs of security measures, and
  • The likelihood and the possible impact of potential risks to e-PHI.6 Covered entities must review and modify their security measures to continue protecting e-PHI in a changing environment.

To read the full Summary of the HIPPA Security Rule from the U.S. Department of Health & Human Services, click here. To download the 2021 Attestation Letter for the HIPAA/HITECH Security Risk Assessment, click here. GDPR vs HIPAA – What are the differences and how to comply