The Honorable Patrick J. Leahy
U.S. Senate
Washington, DC 20510
Dear Senator Leahy:

The American Association for Clinical Chemistry (AACC), representing nearly 11,000 clinical laboratory professionals, supports your efforts, as outlined in S.1368, the "Medical Information Privacy and Security Act," to protect individuals from discrimination on the basis of their medical data. We strongly agree that identifiable health information must remain confidential, unless the patient authorizes release of such data. However, AACC does have a number of concerns regarding the legislation. Our specific comments follow:

Sections 101(a)(1) Right of Individual & (a)(2) Procedures and Fees

S.1368 states that an individual has the right to inspect and copy their own ‘protected’ health information, as long as they agree to pay for the costs associated with inspecting and copying the document. The bill also states that the provider has 15 days to comply with this request. AACC believes these recommendations are reasonable and supports their enactment.

Sections 102(b) Refusal to Supplement & 102(c) Statement of Disagreement

The legislation would also permit individuals to request that the health care provider add supplemental data to their medical records. If the provider denies the request, the individual could file a statement with the provider disputing the decision. In any subsequent disclosure of the disputed information, the provider would be required to include a copy of the patient’s statement and, if requested, the provider’s reasoning for not adding the supplemental information to the medical record. AACC believes that this section is too broadly written and will unnecessarily increase the administrative burden on clinical laboratories.

We agree that patients, who perceive errors in their medical records, should be able to request and obtain a correction to their records. However, the laboratory is not the appropriate provider for maintaining supplemental information. Without the patient’s complete medical record, the laboratory is unable to confirm whether the patient’s request is valid or not. The only person who can make that determination is the primary care physician. Thus, we recommend that the supplemental data option be limited to the primary care provider, who could determine whether the patient’s inquiry was valid and who would be the source of most inquiries.

Sections 112(2)(b) Maintenance of Record & 202(h) Record of Individual’s Authorizations and Revocations

These sections stipulate that each person collecting or storing personally identifiable health information shall maintain a record for a period of seven years of each authorization and revocation, and that such data will become part of the person’s identifiable health information. We recommend that you change these provisions to make them consistent with the Medicare conditions of participation for hospitals, which require hospitals to maintain patient records for five years.

Sections 202(f) Segregation of Files

This bill also states that, at the request of an individual, the health care provider must "segregate any type or amount of protected health information, other than administrative billing information, held by the entity." In addition, the provider must "maintain such information outside any networked computerized, digital, optical or other electronic system." Although AACC agrees there should be restrictions on whom, or what entities should have access to a patient’s medical information. However, we do not believe that protected health information should be segregated from the patient’s chart.

Most medical data are now in electronic format. To segregate protected data separately, in a non-electronic format, will be costly, place an additional administrative burden on providers and will not provide the patient greater privacy. In fact, a notation on the patient’s file indicating the existence of segregated data may be as damaging to the patient as the protected information itself. More important, separating this data from the patient’s record increases the risk that such data may be excluded from important medical decisions. We recommend that S.1368 be modified to place the emphasis on increased penalties for the negligent or intentional disclosure of protected information, rather than segregating the data.

Section 301 Establishment

This section would establish an Office of Health Information within the Department of Health and Human Services to carry out the activities specified under this legislation. AACC does not agree with this recommendation. A new government office is not necessary to implement the provisions set forth under this bill. If enacted, AACC urges you to use the existing regulatory framework to coordinate program activities.

By way of background, AACC is the principal association of professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and to help maintain high professional standards.

If you have any questions or we may be of any assistance, please call me at (717) 531-8316 or Vince Stine, Manager, Government Affairs at (202) 835-8721.



Stephen Kahn, PhD, DABCC


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