legal agency protected health information

6. Uses and disclosures for governmental health data systems. (§
164.510(g))

Please label comments about this section with the subject:
“Governmental health data systems”

In § 164.510(g), we propose to permit covered entities to disclose
protected health information for inclusion in State or other
governmental health data systems without individual authorization when
such disclosures are authorized by State or other law in support of
policy, planning, regulatory or management functions.

a. Importance of Governmental health data systems and the need for
protected health information.

Governmental agencies collect and analyze individually identifiable
health information as part of their efforts to improve public policies
and program management, improve health care and reduce costs, and
improve information available for consumer choices. Governments use
the information to analyze health care outcomes, quality, costs and
patterns of utilization, effects of public policies, changes in the
health care delivery system, and related trends. These important
purposes are related to public health, research and oversight
(although the information in State or other governmental data systems
usually is not collected specifically to audit or evaluate health care
providers or for public health surveillance). The data are an
important resource that can be used for multiple public policy
evaluations.

The collection of health information by governmental health data
systems often occurs without specification of the particular analyses
that could be conducted with the information. These governmental data
collection programs frequently call for reporting of information for
all individuals treated or released by specified classes of providers.
For example, many States request and receive from hospitals records
containing individual diagnosis and treatment data for all discharges
from their facilities. State hospital discharge data have been used to
compare treatment practices and costs between hospitals, to evaluate
implications for funding of health care, as well as to provide
hospital “report cards” to consumers. As part of its general
evaluation activities, the DOD maintains a very large database, called
the Comprehensive Clinical Evaluation Program, involving military
personnel who have reported illnesses possibly arising from service
during the Gulf War.

b. Proposed requirements.

We propose to permit covered entities to disclose protected health
information for inclusion in State or other governmental health data
systems when such disclosure is authorized by law for analysis in
support of policy, planning, regulatory, and management functions. The
recipient of the information must be a government agency (or privacy
entity acting on behalf of a government agency). Where the covered
entity is itself a government agency that collects health data for
analysis in support of policy, planning, regulatory, or management
functions, it would be permitted to use protected health information
in all cases in which it is permitted to disclose such information for
government health data systems under this section.

We believe that Congress intended to permit States, Tribes,
territories, and other governmental agencies to operate health data
collection systems for analyzing and improving the health care system.
In section 1178(c), “State regulatory reporting,” HIPAA provides that
it is not limiting the ability of a State to require a health plan to
report, or to provide access to, information for a variety of
oversight activities, as well as for “program monitoring and
evaluation.” We also believe that the considerations Congress applied
to State capacities to collect data would apply to similar data
collection efforts by other levels of government, such as those
undertaken by Tribes, territories and federal agencies. Therefore, we
considered two questions regarding governmental health data systems;
first, which entities could make such disclosures; and second, what
type of legal authority would be necessary for the disclosure to be
permitted.

We considered whether to allow disclosure by all covered entities to
governmental data collection systems or to limit permitted disclosures
to those made by health plans, as specified in the regulatory
reporting provision of HIPAA. While this provision only mentions data
collected from health plans, the conference agreement notes that laws
regarding “State reporting on health care delivery or costs, or for
other purposes” should not be preempted by this rule. States would be
likely to require sources of information other than health plans, such
as health care providers or clearinghouses, in order to examine health
care delivery or costs. Therefore, we do not believe it is appropriate
to restrict States’ or other governmental agencies’ ability to obtain
such data. This viewpoint is consistent with the Recommendations,
which would permit this disclosure of protected health information by
all covered entities.

We also asked what type of law would be required to permit disclosure
without individual authorization to governmental health data systems.
We considered requiring a specific statute or regulation that requires
the collection of protected health information for a specified
purpose. A law that explicitly addresses the conditions under which
protected health information is collected would provide individuals
and covered entities with a better understanding of how and why the
information is to be collected and used.

We understand, however, that explicit authority to collect information
is not always included in relevant law. Governmental agencies may
collect health data using a broad public health or regulatory
authority in statute or regulation. For example, a law may call on a
State agency to report on health care costs, without providing
specific authority for the agency to collect the health care cost data
they need do so. Consequently, the agency may use its general
operating authority to request health care providers to release the
information. We recognize that many governmental agencies rely on
broad legal authority for their activities and do not intend this
proposed rule to hamper those efforts.

Under §164.518(c), covered entities would have an obligation to verify
the identity of the person requesting protected health information,
and the legal authority behind the request before the disclosure would
be permitted under this subsection. Preamble section II.G.3. describes
these requirements in more detail.

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