December 13, 1999
U. S. Department of Health and Human Services
Assistant Secretary for Planning and Evaluation
Attention: Privacy-P
Room G-322A
Hubert H. Humphrey Building
200 Independence Avenue SW
Washington, D. C. 20201
Dear Sirs:
On behalf of the National Committee on Vital and Health Statistics (NCVHS), I am pleased to forward to you our recommendations on the notice of proposed rule-making for standards for privacy of individually identifiable health information. The NCVHS congratulates the Department for the solid work done in drafting this notice of proposed rule-making. The NCVHS is also pleased that many of its recommendations on health information privacy in its June 1997 report have been incorporated into the proposed rule.
While the scope of the proposed rule addresses many health information privacy issues, it should be noted that there is still a need for anti-discrimination legislation. The NCVHS previously urged the Secretary to propose legislation expanding the anti-discrimination provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to cover all aspects of discrimination based on health status and condition.
While the proposed rule meets the requirements of HIPAA, the NCVHS believes that there is a need for comprehensive federal legislation to address the privacy of individually identifiable health information. The proposed rule is limited in scope and does not cover all records or all entities with access to individually identifiable health information.
The NCVHS agrees that the scope of the rule should be extended to all individually identifiable health information, including purely paper records, maintained by covered entities. Having uniform regulations apply to all medical records would simplify the burden of the regulations for covered entities to comply with. The NCVHS also recommends that the proposed rule should cover more than the three covered entities presently identified. It is recommended that extension of current authority under HHS be utilized.
There was a divergence of opinion among the Committee regarding informed consent versus statutory authorization. Concern was expressed that statutory authorization undercut traditional codes of medical ethics and that informed consent should be preserved. However, many NCVHS members felt that statutory authorization provided a better, more uniform level of protection than the case by case application of informed consent.
Additionally, the example of a physician consulting the records of several people in the same family or living in the same household to assist in the diagnosis of conditions that could be contagious or that could arise from a common environmental factor raised concern. A physician would be examining records of others without their informed consent in the treatment of another individual.
The NCVHS supports the concept of minimum necessary use and disclosure. The Committee, however, would add an additional standard: minimum identifiable form. Minimum identifiable form would limit the amount of identifiable data. For example, rather than using name, one would use another identifier. Therefore, any use or disclosure would be the minimum amount of protected health information necessary to accomplish the intended purpose of use or disclosure in a minimum identifiable form.
The NCVHS believes that the current proposal for law enforcement access is overly broad. The general rule for law enforcement access should be based on a warrant. If exigent circumstances exist, notice should be provided to HHS to monitor access.
While a State may submit a written request to the Secretary to except a provision of State law from preemption, it is recommended that the Secretary prior to granting the waiver give notice to the citizens of the State.
The definition of protected health information excludes individually identifiable health information of inmates of correctional facilities and detainees in detention facilities. The NCVHS is opposed to exempting inmates and detainees from the proposed rule.
We appreciate the opportunity to offer these comments and again congratulate the Department on a comprehensive regulation.
Sincerely,
John R. Lumpkin, M. D., M. P. H.
Chair