Data Access

CRE Analysis

1. Scope -- What government activity should trigger Data Access?

Comment by Merck & Co., Inc.

CRE Response:

The use of FOIA as a vehicle for implementing data access has been hotly contested, with opponents of the data access law describing the statute as an ill-suited, even "meat axe" approach. CRE, however, continues to believe that FOIA is highly flexible in its administration and perhaps the most time-tested federal information disclosure statute ever enacted.

Congress has clearly indicated that FOIA's nine exemptions against disclosure will apply under the new data access law. These exemptions permit agencies to withhold information in the following categories:

1. other documents exempted by Executive Order (national security)
2. internal personnel rules and practices
3. documents exempted by statute without discretion of an agency
4. trade secrets and confidential commercial information
5. internal documents that would not be available to a litigant by law
6. personnel and medical files, and other material the disclosure of which would constitute an unwarranted invasion of personal privacy
7. records compiled for law enforcement purposes
8. records relating to oversight of financial institutions
9. geological data regarding wells

Most of the FOIA debate on data access has centered around exemptions 4 and 6 above. Merck & Co.'s April 1 comments, in particular, focus on the protection of intellectual property and therefore draw into question FOIA exemption 4. CRE has written extensively regarding the protections for intellectual property under that exemption. See CRE's April 5, 1999 Comments to OMB at section II.2.2. In addition to the protections under exemption 4, other statutes such as the Technology Transfer Act and the Bayh-Dole Act provide protections for the kinds of studies Merck describes. These statutes are incorporated into FOIA's protections under exemption 3 above.

Concerns over potential invasion of medical privacy also have been raised during the data access debate, often with much fervor. Three points are critical to understanding the fallacy of these arguments. First, FOIA exemption 6, by its plain terms, protects against disclosure of personal medical data. Second, researchers have long been restricted by ethical standards and practices that prohibit the disclosure of patient- identifying data, and nothing in the new data access law runs counter to these standards and practices.

Third, with respect to the disclosure of research data to the funding agency itself (as opposed to the FOIA requester, from whom the private data would remain hidden), federal researchers are already obligated to provide such data to the agency upon request under Circular A-110. Merck and others have opined that research subjects will be scared away from participating in medical studies if it comes out that their records could be disclosed to the government. Such disclosures have always been a possibility in connection with federal research, however, and CRE respectfully points out that researchers' representations to study participants have been in error.

Finally, OMB has significantly clarified the protections afforded to both intellectual property and medical privacy rights in its August 11, 1999 reproposal.