Which HIPAA rules are most open to interpretation?

“A neurologist arrives on a medical ward to perform a consultation. All the charts on the chart rack are turned facing the wall so that no names are visible on viewing it. He must then remove each one individually until he finds the name of the patient on the proper chart.”  This example is provided in the NIH article HIPAA: A Flawed Piece of Legislation.

This action is a direct result of the confusion and over-caution brought on by HIPAA regulations. The ambiguity within these rules has led healthcare providers to take extreme measures to ensure compliance, even when such actions appear nonsensical or unnecessary. The NIH article further states, “Given the vagueness of this criterion and such potentially draconian punishments for any breach in confidentiality, it is no wonder that many health care providers were driven by paranoia to the kinds of absurdities in behavior described above.”

1. The "minimum necessary" standard

According to the Department of Health and Human Services (HHS), “The minimum necessary standard is based on sound current practice that protected health information should not be used or disclosed when it is not necessary to satisfy a particular purpose or carry out a function. The minimum necessary standard requires covered entities to evaluate their practices and enhance safeguards as needed to limit unnecessary or inappropriate access to and disclosure of protected health information. The Privacy Rule’s requirements for minimum necessary are designed to be sufficiently flexible to accommodate the various circumstances of any covered entity.”  

Why is it ambiguous?

• HIPAA does not define specific limits, instead requiring "reasonable safeguards"
• What's "necessary" differs by role, context, and clinical situation
• The standard must balance limiting access with ensuring clinicians have sufficient information

2. "Reasonable safeguards" for verbal communications

45 CFR § 164.530(c) requires covered entities to implement appropriate administrative, technical, and physical safeguards to protect PHI, including measures for verbal communications. For example, safeguarding against disclosing PHI in a public space, or having clear protocols for ensuring that conversations involving PHI do not occur in environments where unauthorized individuals may overhear.

Why is it ambiguous?

• Facility designs and workflows vary across healthcare settings
• The rule acknowledges that some incidental disclosures are unavoidable
• "Reasonableness" must be balanced against patient care efficiency

3. The security rule's "addressable" vs. "required" implementation specifications

The HIPAA Security Rule divides implementation specifications into two categories: "required" and "addressable." While required specifications must be implemented, addressable ones allow organizations to:

1. Implement the specification
2. Implement an alternative measure
3. Not implement anything if reasonable and documented

Why is it ambiguous?

• "Addressable" doesn't mean optional
• Organizations must document their decision-making process
• The "reasonableness" of alternatives remains subjective

4. Business associate relationship determinations

Determining which third-party relationships qualify as business associates continues to challenge many healthcare organizations.

Why is it ambiguous?

• The definition covers entities that "create, receive, maintain, or transmit" PHI
• Some vendor relationships involve only occasional, incidental access to PHI
• Cloud service providers and other technology vendors may have technical access but no intended access

5. De-identification standards

Section 164.514(a) of the HIPAA Privacy Rule provides the standard for de-identification of protected health information.  Under this standard, health information is not individually identifiable if it does not identify an individual and if the covered entity has no reasonable basis to believe it can be used to identify an individual.

HIPAA provides two methods for de-identifying PHI: the Expert Determination Method and the Safe Harbor Method. However, both leave room for interpretation.

Why is it ambiguous?

• The Expert Determination Method relies on "appropriate knowledge and experience" to determine "very small" re-identification risk
• The Safe Harbor Method removes 18 identifiers but includes the catch-all category of "any other unique identifying characteristic"
• Neither method fully addresses modern re-identification techniques using big data

6. "Reasonable" security risk analysis requirements

The Security Rule requires organizations to conduct a "thorough and accurate" risk analysis, but provides minimal specifics about methodology or frequency.

Why is it ambiguous?

• No required framework or methodology is specified
• No mandated frequency (beyond "regular review")
• No specific documentation requirements

7. Permissible disclosures for "healthcare operations"

45 CFR § 164.506 outlines the conditions under which covered entities can disclose PHI for purposes related to health care operations without obtaining patient consent or authorization.

The regulation allows disclosures for broadly defined "health care operations," which creates challenges in interpretation.

Why is it ambiguous?

• The definition includes numerous activities from quality assessment to business planning
• The line between marketing (requiring authorization) and operations (not requiring authorization) can blur
• The boundary between research and quality improvement activities remains fuzzy

Navigating the gray areas

Healthcare organizations can take several approaches to navigate HIPAA's ambiguities:

1. Document your reasoning: When making interpretive decisions, document your analysis, factors considered, and conclusion.
2. Seek multiple perspectives: Involve legal counsel, compliance officers, and operational leaders in interpreting ambiguous provisions.
3. Stay current with OCR guidance: The Office for Civil Rights periodically issues guidance clarifying ambiguous provisions.
4. Learn from enforcement actions: OCR's resolution agreements often reveal their interpretation of ambiguous rules.
5. Apply the "wall street journal test": Would your interpretation seem reasonable if described on the front page of a major newspaper?

FAQs

How can healthcare providers minimize the risk of HIPAA violations due to ambiguity?

By implementing clear internal policies, training staff regularly, and seeking legal counsel for complex situations.

Are there any updates or proposed changes to HIPAA that could address these ambiguities?

The Office for Civil Rights periodically issues guidance and may propose updates to clarify these gray areas.

What are the consequences of misinterpreting HIPAA rules?

Misinterpretation can lead to compliance violations, fines, legal actions, and damage to a provider's reputation.