Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Section 164.530(c) - Safeguards


Comments: A few comments assert that the rule requires some institutions that do not have adequate resources to develop costly physical and technical safeguards without providing a funding mechanism to do so. Another comment said that the vague definitions of adequate and appropriate safeguards could be interpreted by HHS to require the purchase of new computer systems and reprogram many old ones. A few other comments suggested that the safeguards language was vague and asked for more specifics.

Response: We require covered entities to maintain safeguards adequate for their operations, but do not require that specific technologies be used to do so. Safeguards need not be expensive or high-tech to be effective. Sometimes, it is an adequate safeguard to put a lock on a door and only give the keys to those who need access. As described in more detail in the preamble discussion of § 164.530, we do not require covered entities to guarantee the safety of protected health information against all assaults. This requirement is flexible and scalable to allow implementation of required safeguards at a reasonable cost.

Comments: A few commenters noted that once protected health information becomes non-electronic, by being printed for example, it escapes the protection of the safeguards in the proposed Security Rule. They asked if this safeguards requirement is intended to install similar security protections for non-electronic information.

Response: This provision is not intended to incorporate the provisions in the proposed Security regulation into this regulation, or to otherwise require application of those provisions to paper records.

Comments: Some commenters said that it was unclear what "appropriate" safeguards were required by the rule and who establishes the criteria for them. A few noted that the privacy safeguards were not exactly the same as the security safeguards, or that the 'other safeguards' section was too vague to implement. They asked for more clarification of safeguards requirements and flexible solutions.

Response: In the preamble discussion of § 164.530, we provide examples of types of safeguards that can be appropriate to satisfy this requirement. Other sections of this regulation require specific safeguards for specific circumstances. The discussion of the requirements for "minimum necessary' uses and disclosures of protected health information includes related guidance for developing role-based access policies for a covered entity's workforce. The requirements for "component entities" include requirements for firewalls to prevent access by unauthorized persons. The proposed Security Rule included further details on what safeguards would be appropriate for electronic information systems. The flexibility and scalability of these rules allows covered entities to analyze their own needs and implement solutions appropriate for their own environment.

Comments: A few comments asked for a requirement for a firewall between a health care component and the rest of a larger organization as another appropriate safeguard.

Response: We agree, and have incorporated such a requirement in § 164.504.

Comments: One commenter agreed with the need for administrative, physical, and technical safeguards, but took issue with our specification of the type of documentation or proof that the covered entity is taking action to safeguard protected health information.

Response: This privacy rule does not require specific forms of proof for safeguards.

Comments: A few commenters asked that, for the requirement for a signed certification of training and the requirements for verification of identity, we consider the use of electronic signatures that meet the requirements in the proposed security regulation to meet the requirements of this rule.

Response: In this final rule, we drop the requirements for signed certifications of training. Signatures are required elsewhere in this regulation, for example, for a valid authorization. In the relevant sections we clarify that electronic signatures are sufficient provided they meet standards to be adopted under HIPAA. In addition, we do not intend to interfere with the application of the Electronic Signature in Global and National Commerce Act.

Comments: A few commenters requested that the privacy requirements for appropriate administrative, technical, and physical safeguards be considered to have been met if the requirements of the proposed Security Rule have been met. Others requested that the safeguards requirements of the final Privacy Rule mirror or be harmonized with the final Security Rule so they do not result in redundant or conflicting requirements.

Response: Unlike the proposed regulation, the final regulation covers all protected health information, not just information that had at some point been electronic. Thus, these commenters' assumption that the proposed Privacy Rule and the proposed Security Rule covered the same information is not the case, and taking the approach suggested by these comments would leave a significant number of health records unprotected. The safeguards required by this regulation are appropriate for both paper and electronic information. We will take care to ensure that the final Security Rule works in tandem with these requirements.

Comments: One commenter requested that the final privacy rule be published before the final Security Rule, recognizing that the privacy policies must be in place before the security technology used to implement them could be worked out. Another commenter asked that the final Security Rule be published immediately and not wait for an expected delay while privacy policies are worked out.

Response: Now that this final privacy rule has been published in a timely manner, the final Security Rule can be harmonized with it and published soon.

Comments: Several commenters echoed an association recommendation that, for those organizations that have implemented a computer based patient record that is compliant with the requirements of the proposed Security Rule, the minimum necessary rule should be considered to have been met by the implementation of role-based access controls.

Response: The privacy regulation applies to paper records to which the proposed Security Rule does not apply. Thus, taking the approach suggested by these comments would leave a significant number of health records unprotected. Further, since the final Security Rule is not yet published and the number of covered entities that have implemented this type of computer-based patient record systems is still small, we cannot make a blanket statement. We note that this regulation requires covered entities to develop role-based access rules, in order to implement the requirements for "minimum necessary" uses and disclosures of protected health information. Thus, this regulation provides a foundation for the type of electronic system to which these comments refer.