Public Health FAQs
| Frequently Asked Questions [source: Standards for Privacy of Individually Identifiable Health Information (45 CFR Parts 160 and 164) - December 3, 2002] |
Must a health care provider or other covered entity obtain permission from a patient prior to notifying public health authorities of the occurrence of a reportable disease? Does the public health provision of the HIPAA Privacy Rule require covered entities to make public health disclosures? May covered entities disclose facially identifiable protected health information, such as name, address, and social security number, for public health purposes? Does the HIPAA Privacy Rule’s public health provision permit covered entities to disclose protected health information to authorities such as the National Institutes of Health (NIH)? To whom may covered entities make public health disclosures regarding a product regulated by the Food and Drug Administration (FDA) when more than one person is identified on the product label? Is a covered entity permitted to disclose protected health information under the HIPAA Privacy Rule’s public health provision when the link between an adverse event and a product regulated by the Food and Drug Administration (FDA) is only suspected? Does the HIPAA Privacy Rule’s public health provision permit covered entities to disclose protected health information without authorization to a manufacturer of a product regulated by the Food and Drug Administration (FDA) for use by the manufacturer to assess the effectiveness of its marketing campaign? Does the HIPAA Privacy Rule’s public health provision permit covered health care providers to disclose protected health information concerning the findings of pre-employment physicals, drug tests, or fitness-for-duty examinations to an individual’s employer? Q: Must a health care provider or other covered entity obtain permission from a patient prior to notifying public health authorities of the occurrence of a reportable disease? A: No. All States have laws that require providers to report cases of specific diseases to public health officials. The HIPAA Privacy Rule permits disclosures that are required by law. Furthermore, disclosures to public health authorities that are authorized by law to collect or receive information for public health purposes are also permissible under the Privacy Rule. In order to do their job of protecting the health of the public, it is frequently necessary for public health officials to obtain information about the persons affected by a disease. In some cases they may need to contact those affected in order to determine the cause of the disease to allow for actions to prevent further illness. The Privacy Rule continues to allow for the existing practice of sharing protected health information with public health authorities that are authorized by law to collect or receive such information to aid them in their mission of protecting the health of the public. Examples of such activities include those directed at the reporting of disease or injury, reporting deaths and births, investigating the occurrence and cause of injury and disease, and monitoring adverse outcomes related to food (including dietary supplements), drugs, biological products, and medical devices. See the fact sheet and frequently asked questions on this web site about the public health provision for more information. Back to Top Q: Does the public health provision of the HIPAA Privacy Rule require covered entities to make public health disclosures? A: No. The Privacy Rule’s public health provision permits, but does not require, covered entities to make such disclosures. This provision is intended to allow covered entities to continue current voluntary reporting practices that are critically important to public health and safety. The Rule also permits covered entities to disclose protected health information when State or other law requires covered entities to make disclosures for public health purposes. For instance, many State laws require health care providers to report certain diseases, cases of child abuse, births, or deaths, and the Privacy Rule permits covered entities to disclose protected health information, without authorization, to make such reports. See the fact sheet and frequently asked questions on this web site about the public health provision for more information. Back to Top Q: May covered entities disclose facially identifiable protected health information, such as name, address, and social security number, for public health purposes? A: Yes. The HIPAA Privacy Rule permits covered entities to disclose the amount and type of protected health information that is needed for public health purposes. In some cases, the disclosure will be required by other law, in which case, covered entities may make the required disclosure pursuant to 45 CFR 164.512(a) of the Rule. For disclosures that are not required by law, covered entities may disclose, without authorization, the information that is reasonably limited to that which is minimally necessary to accomplish the intended purpose of the disclosure. For routine or recurring public health disclosures, a covered entity may develop protocols as part of its minimum necessary policies and procedures to address the type and amount of information that may be disclosed for such purposes. Covered entities may also rely on the requesting public health authority’s determination of the minimally necessary information. See the fact sheet and frequently asked questions on this web site about the public health and minimum necessary standards for more information. Back to Top Q: Does the HIPAA Privacy Rule’s public health provision permit covered entities to disclose protected health information to authorities such as the National Institutes of Health (NIH)? A: The definition of a “public health authority” requires that an agency’s official mandate include the responsibility for public health matters. The mandate can be responsibility for public health matters, generally, or it can be for specific public health programs. Furthermore, an agency’s official mandate does not have to be exclusively or primarily for public health. Therefore, to the extent a government agency has public health matters as part of its official mandate, it qualifies as a public health authority. For instance, various Department of Health and Human Service agencies, such as NIH and the Health Resources and Services Administration (HRSA), are authorized by law to assist the Secretary of Health and Human Services in carrying out the purposes of section 301 of the Public Health Service Act. Those agencies are public health authorities under the Rule, even if they have other non-public health mandates. To the extent a public health authority is authorized by law to collect or receive information for the public health purposes specified in the public health provision, covered entities may disclose protected health information to such public health authorities without authorization pursuant to the public health provision. See the fact sheet and frequently asked questions on this web site about the public health provision for more information. Back to Top Q: To whom may covered entities make public health disclosures regarding a product regulated by the Food and Drug Administration (FDA) when more than one person is identified on the product label? A: Covered entities may identify persons responsible for an FDA-regulated product by using the product label, the literature that accompanies the product, or other sources of labeling, such as the Physician’s Desk Reference. If multiple persons are named, covered entities may choose any of the persons named by these sources. See the fact sheet and frequently asked questions on this web site about the public health provision for more information. Back to Top Q: Is a covered entity permitted to disclose protected health information under the HIPAA Privacy Rule’s public health provision when the link between an adverse event and a product regulated by the Food and Drug Administration (FDA) is only suspected? A: Yes. In most instances when a covered entity makes an adverse event report to a person responsible for an FDA-regulated product, the covered entity will suspect, but not know, the product is the cause of the event. Determining whether the product is related to the adverse event almost always requires follow up with the covered entity which in turn may need further contact with the patient. FDA and product manufacturers receive a great deal of important information about the safety of regulated products from these reports. To limit such reports to those instances where the covered entity is convinced of the link between the product and the event would reduce the amount of useful safety, quality and effectiveness data available to the agency as well as to product manufacturers. This would limit significantly FDA’s ability to protect the public health by helping to assure that only safe and effective products are marketed in the U.S. Accordingly, covered entities may disclose the minimum amount of protected health information that is reasonably necessary to report suspected adverse events associated with an FDA-regulated product. See the fact sheet and frequently asked questions on this web site about the public health and minimum necessary standards for more information. Back to Top Q: Does the HIPAA Privacy Rule’s public health provision permit covered entities to disclose protected health information without authorization to a manufacturer of a product regulated by the Food and Drug Administration (FDA) for use by the manufacturer to assess the effectiveness of its marketing campaign? A: No. The public health provision is intended to facilitate the flow of information that is essential to the FDA’s public health mission. The provision does not permit covered entities to disclose protected health information to a manufacturer for the manufacturer’s commercial purposes, or for any other non-public health purpose. For example, the Rule does not permit a covered entity to provide a drug manufacturer with a list of persons who prefer a different flavored cough syrup over the flavor of the manufacturer’s product. Rather, this provision permits covered entities to disclose protected health information as necessary to continue current voluntary reporting of adverse events and similar reports that are necessary to ensure the quality, safety, or effectiveness of an FDA-regulated product. For instance, a covered entity would be permitted to report a concern to a drug manufacturer that its cough syrup might be unsafe based on the belief that a difference in the taste could be due to drug tampering or a manufacturing problem. Likewise, a covered health care provider would be permitted to disclose protected health information to a drug manufacturer to report that the failure of a patient’s medical condition to improve may be due to the drug’s ineffectiveness. In making such a report, the covered entity may disclose the protected health information that is reasonably necessary to achieve the purpose of the report. See the fact sheet and frequently asked questions on this web site about the public health and minimum necessary standards for more information. Back to Top Q: Does the HIPAA Privacy Rule’s public health provision permit covered health care providers to disclose protected health information concerning the findings of pre-employment physicals, drug tests, or fitness-for-duty examinations to an individual’s employer? A: The public health provision permits covered health care providers to disclose an individual’s protected health information to the individual’s employer without authorization in very limited circumstances. First, the covered health care provider must provide the health care service to the individual at the request of the individual’s employer or as a member of the employer’s workforce. Second, the health care service provided must relate to the medical surveillance of the workplace or an evaluation to determine whether the individual has a work-related illness or injury. Third, the employer must have a duty under the Occupational Safety and Health Administration (OSHA), the Mine Safety and Health Administration (MSHA), or the requirements of a similar State law, to keep records on or act on such information. For example, OSHA requires employers to monitor employees’ exposures to certain substances and to take specific actions when an employee’s exposure level exceeds a specified limit. A covered entity which tests an individual for such an exposure level at the request of the individual’s employer may disclose that test result to the employer without authorization. Generally, pre-placement physicals, drug tests, and fitness-for-duty examinations are not performed for such purposes. However, to the extent such an examination is conducted at the request of the employer for the purpose of such workplace medical surveillance or work-related illness or injury, and the employer needs the information to comply with the requirements of OSHA, MSHA, or similar State law, the protected health information the employer needs to meet such legal obligation may be disclosed to the employer without authorization. Covered health care providers who make such disclosures must provide the individual with written notice that the information is to be disclosed to his or her employer (or by posting the notice at the worksite if the service is provided there). When a health care service does not meet the above requirements, covered entities may not disclose an individual’s protected health information to the individual’s employer without an authorization, unless the disclosure is otherwise permitted without authorization by other provisions of the Rule. However, nothing in the Rule prohibits an employer from conditioning employment on an individual providing an authorization for the disclosure of such information. Back to Top |