Comment: We received a number of comments supporting the exception for disclosure of protected health information to government health data systems. Some supporters stated a general belief that the uses of such information were important to improve and protect the health of the public. Commenters said that state agencies used the information from government health data systems to contribute to the improvement of the health care system by helping prevent fraud and abuse and helping improve health care quality, efficiency, and cost-effectiveness. Commenters asserted that state agencies take action to ensure that data they release based on these data systems do not identify individuals
We also received a large volume of comments opposed to the exception for use and disclosure of protected health information for government health data systems. Many commenters expressed general concern that the provision threatened their privacy, and many believed that their health information would be subject to abuse by government employees. Commenters expressed concern that the provision would facilitate collection of protected health information in one large, centralized government health database that could threaten privacy. Others argued that the proposed rule would facilitate law enforcement access to protected health information and could, in fact, become a database for law enforcement use.
Many commenters asserted that this provision would make individuals concerned about confiding in their health care providers. Some commenters argued that the government should not be allowed to collect individually identifiable health information without patient consent, and that the government could use de-identified data to perform the public policy analyses. Many individual commenters said that HHS lacked statutory and Constitutional authority to give the government access and control of their medical records without consent.
Many commenters believed that the NPRM language on government health data systems was too broad and would allow virtually any government collection of data to be covered. They argued that the government health data system exception was unnecessary because there were other provisions in the proposed rules providing sufficient authority for government agencies to obtain the information they need.
Some commenters were concerned that the NPRM's government health data system provisions would allow disclosure of protected health information for purposes unrelated to health care. These commenters recommended narrowing the provision to allow disclosure of protected health information without consent to government health data systems in support of health care-related policy, planning, regulatory, or management functions. Others recommended narrowing the exception to allow use and disclosure of protected health information for government health databases only when a specific statute or regulation has authorized collection of protected health information for a specific purpose.
Response: We agree with the commenters who suggested that the proposed provision that would have permitted disclosures to government health data bases was overly broad, and we remove it from the final rule.
We reviewed the important purposes identified in the comments for government access to protected health information, and believe that the disclosures of protected health information that should appropriately be made without individuals' authorization can be achieved through the other disclosures provided for in the final rule, including provisions permitting covered entities to disclose information (subject to certain limitations) to government agencies for public health, research, health oversight, law enforcement, and otherwise as required by law. For example, the final rule continues to allow a covered entity to disclose protected health information without authorization to a public health authority to monitor trends in the spread of infectious disease, morbidity, and mortality. Under the rule's health oversight provision, covered entities can continue to disclose protected health information to public agencies for purposes such as analyzing the cost and quality of services provided by covered entities; evaluating the effectiveness of federal, state, and local public programs; examining trends in health insurance coverage of the population; and analyzing variations in access to health coverage among various segments of the population. We believe that it is better to remove the proposed provision for government health data systems generally and to rely on other, more narrowly tailored provisions in the rule to authorize appropriate disclosures to government agencies.
Comment: Some provider groups, private companies, and industry organizations recommended expanding the exception for government health data systems to include data collected by private entities. These commenters said that such an expansion would be justified, because private entities often perform the same functions as public agencies collecting health data.
Response: We eliminate the exception for government health data systems because it was over broad and the uses and disclosures we were trying to permit are permitted by other provisions. We note that private organizations may use or disclose protected health information pursuant to multiple provisions of the rule.
Comment: One commenter recommended clarifying in the final rule that the government health data system provisions apply to: (1) manufacturers providing data to HCFA and its contractors to help the agency make reimbursement and related decisions; and to (2) third-party payors that must provide data collected by device manufacturers to HCFA to help the agency make reimbursement and related decisions.
Response: The decision to eliminate the general provision permitting disclosures to government health data systems makes this issue moot with respect to such disclosures. We note that the information used by manufacturers to support coverage determinations often is gathered pursuant to patient authorization (as part of informed consent for research) or as an approved research project. There also are many cases in which information can be de-identified before it is disclosed. Where HCFA hires a contractor to collect such protected health information, the contractor may do so under HCFA's authority, subject to the business associate provisions of this rule.
Comment: One commenter recommended stating in the final rule that de-identified information from government health data systems can be disclosed to other entities.
Response: HHS does not have the authority to regulate re-use or re-disclosure of information by agencies or institutions that are not covered entities under the rule. However, we support the policies and procedures that public agencies already have implemented to de-identify any information that they redisclose, and we encourage the continuation of these activities.