Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2 Modernizing Pandemic Response Strategies (2020) / Chapter Skim
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5 Governance and Regulatory Considerations
5 Governance and Regulatory Considerations
Pages 69-84
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From page 69... ...
for national public health surveillance purposes, sharing such data is voluntary and is typically limited to epidemiological data, not viral sequence data. Consequently, absent a state law mandate, such sharing takes place voluntarily.
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From page 70... ...
FEDERALISM BARRIERS AND OPPORTUNITIES The need for rapid and comprehensive viral sequence sharing may also serve as an opportunity for addressing barriers inherent in the federal system to data sharing. Given the national and interstate threat posed by a pandemic like COVID-19, there is an important rationale for shifting sharing from purely intrastate and voluntary to federal authorities, to interstate and federal data sharing, either through formalized voluntary agreements contingent on state consent (similar to arrangements in other federations)
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From page 71... ...
While the IHR do not currently contain an express obligation to share virus genome sequences, likely reforms of the IHR following the COVID-19 pandemic may serve as an opportunity for crystalizing potential obligations to share virus genome sequence data among countries and WHO (Rourke et al., 2020)
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From page 72... ...
should be a priority. Below, the committee examines two federal laws commonly cited as barriers to data sharing -- the Health Insurance Portability and Accountability Act (HIPAA)
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From page 73... ...
. The HIPAA Privacy Rule also permits the use and disclosure of a limited dataset, which is still PHI but has been rendered less identifiable by the removal of 16 com 3 Health Insurance Portability and Accountability Act of 1996, H.R.
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From page 74... ...
The minimum necessary standard does not apply to such disclosures;8 as a result, entities may disclose in accordance with legal mandates without needing to consider whether such disclosure meets the minimum necessary standard. 6 Health Insurance Portability and Accountability Act of 1996, H.R.
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From page 75... ...
-- whether for public health practice or for research purposes -- would be permitted under the Privacy Rule provisions governing disclosures to public health authorities (HHS, 2020a)
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From page 76... ...
for "public health surveillance."13 Unlike with respect to HIPAA, the definition of "public health surveillance" is not interpreted to mean any activity conducted by a public health authority, including research activities. However, the definition of public health surveillance is quite broad and arguably supports the collection and analysis of data and biospecimens by public health authorities.
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From page 77... ...
. Secondary research involves research on biospecimens or data that were originally collected or generated for a non-research purpose -- such as for clinical purposes and/or for reporting to public health (the information collected to study SARS-CoV-2 is likely to all be secondary data, not generated solely for purposes of SARS-CoV-2 research)
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From page 78... ...
; • Describes the information or biospecimens that might be used in research, whether the information or biospecimens might be shared for research purposes, and the types of institutions or researchers who might conduct the research; • Describes the period of time the database is to be maintained; • Includes a statement that the participant will not be informed of the details of any specific research studies using his or her data or biospecimens, including purposes that he or she might not have chosen to consent to if he or she had the option to do so; • Includes a statement that no clinically relevant research results will be shared with the participant unless it is certain that such results will always be shared; • Includes a statement that participation in the database is volun tary and that there is no penalty or loss of benefits for refusal to participate (and that the individual can discontinue participation prospectively at any time) ; • Includes disclosure of any reasonably foreseeable risks or discom forts, as well as disclosure of any benefits to the subject or others; • Includes the extent to which confidentiality of records will be main tained; and • Includes information about whom to contact with further ques tions or if the participant thinks he or she may have suffered a research-related injury.19 If identifiable biospecimens are collected, the broad consent must include the following (if appropriate)
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From page 79... ...
State laws may also govern the ability of these atypical data sources -- as well as sources covered by HIPAA and the Common Rule -- to share data. State health privacy laws typically cover more sensitive types of information such as mental health, human genome, substance abuse treatment, and repro 20 The Common Rule.
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From page 80... ...
There is a critical role for the federal government to play in coordinating and leading the sharing of such data between states and to the federal government. Given the interstate threat posed by a national public health emergency, this could serve as a moment to shift sharing from purely intrastate and voluntary to federal authorities, to interstate and federal sharing -- through state consent and agreement (similar to arrangements in other federations like Australia and Canada)
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From page 81... ...
• A board with diverse relevant expertise should be established with broad authority to oversee and advise the national strategy for SARS-CoV-2 genome sequences linked to clinical and epide miological data, and the delivery of actionable data for related investigations. CONCLUDING REMARKS Although federal law permits the sources of data and biospecimens to disclose these materials to public health authorities, and to make them available for research -- often without the need to obtain an individual's consent -- confusion about the law, and conservative interpretations due to fear of running afoul of the law, translate into genuine obstacles to sharing.
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From page 82... ...
Such enforcement discretion should have a clear trigger -- and an end point. For example, upon a triggering event such as the declaration of a national public health emergency by the Secretary of HHS, sharing of a limited dataset of PHI with public health authorities or their designees, by covered entities or business associates, could be expressly deemed to be in compliance with the HIPAA Privacy Rule, either without the need for a data use agreement or upon execution of a single standard data use agreement provided by HHS, and without regard to contrary provisions in a business associate agreement.
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From page 83... ...
. There is also an important opportunity to a ssess whether other existing federal laws insufficiently enable viral sequence sharing with a federal authority, and appropriate voluntary agreements between states and the federal government, federal funding requirements, or federal data sharing floor preemption laws, during a public health emergency.
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From page 84... ...
2020c. OCR announces notification of enforcement discretion to allow uses and dis closures of protected health information by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.
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