Introduction: Sharing Data in a Medical Information Commons

P.A. Deverka , M.A. Majumder , A.G. Villanueva , and M. Anderson et al., “Creating a Data Resource: What Will It Take to Build a Medical Information Commons?” Genome Medicine 9, no. 84 (2017): 1-5, available at <https://genomemedicine.biomedcentral.com/articles/10.1186/s13073-017-0476-3> (last visited January 3, 2019).

A.G. Villanueva , R. Cook-Deegan , B.A. Koenig , and P.A. Deverka et al., “Characterizing the Biomedical Data-Sharing Landscape,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 21-30; The sources of data include databases created for many different purposes. In genomics, most were created to collect data for researchers, but many genomic databases are now used in health care. Some databases, such as cancer registries, were established for public health surveillance, but are highly useful for both research and clinical care. Testing laboratories are a direct source of many data — for example, genomic testing laboratories, clinical laboratories, and imaging facilities. Moreover, as medical records are increasingly digitized, unstructured data are being transformed into forms that enable analysis of health outcomes and for other purposes. Also, many efforts are underway to integrate social determinants of health, genomic, imaging and laboratory data into electronic health records. The users of data include scientists hoping to understand biology or disease, but also health professionals helping individuals make decisions about health care interventions, counseling them about the meaning of data. Increasingly, individuals are using health and genomic data themselves.

See Villanueva, supra note 2; J.M. Bollinger , A. Sanka , L. Dolman , and R. Liao et al., “BRCA1/2 Variant Data-Sharing Practices,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 88-96 (see discussion of ClinVar and ClinGen in particular); M.A. Curnutte, K.L. Frumovitz, M.A. Majumder, and A.L. McGuire et al., “One Technology, Multiple Applications: Developing Context-Specific NGS Policy,” Nature Biotechnology 34, no. 5 (2016): 466–470, available at <https://doi.org/10.1038/nbt.3545> (last visited January 3, 2019).

National Center for Biotechnology Information, GenBank Overview, GenBank Website, available at <https://www.ncbi.nlm.nih.gov/genbank/> (last visited December 21, 2018); EMBL-EBBI, European Nucleotide Archive, ENA Website, available at <https://www.ebi.ac.uk/ena> (last visited January 3, 2019), and DDBJ Center Website, available at <https://www.ddbj.nig.ac.jp/index-e.html> (last visited January 3, 2019); See also H. Stevens, Life Out of Sequence: A Data-Driven History of Bioinformatics (Chicago, IL: University of Chicago Press; 2013) and S. Hilgartner, Reordering Life: Knowledge and Control in the Genomics Revolution (Cambridge, MA: MIT Press, 2017).

See M.A. Rothstein , B.M. Knoppers , and H.L. Harrell , “Comparative Approaches to Biobanks and Privacy,” Journal of Law, Medicine & Ethics 44, no. 1 (2016): 161-172, available at <https://doi.org/10.1177/1073110516644207> (last visited January 3, 2019).

N.A. Garrison , “Genomic Justice for Native Americans: Impact of the Havasupai Case on Genetic Research,” Science, Technology & Human Values 38, no. 2 (2013): 201–223, available at <https://doi.org/10.1177/0162243912470009> (last visited January 3, 2019).

See M.A. Majumder , R. Cook-Deegan , and A.L. McGuire , “Beyond Our Borders? Public Resistance to Global Genomic Data Sharing,” PLoS Biol 14, no. 11 (2016): e2000206, available at <https://doi.org/10.1371/journal.pbio.2000206> (last visited January 3, 2019).

H. Rehm , J.S. Berg , and S.E. Plon , “ClinGen and ClinVar – Enabling Genomics in Precision Medicine,” Human Mutation 39, no. 11 (2018), available at <https://doi.org/10.1002/humu.23654> (last visited January 3, 2019); M.J. Landrum and B.L Kattman, “ClinVar at Five Years: Delivering on the Promise,” Human Mutation 39, no. 11 (2018), available at <https://doi.org/10.1002/humu.23641> (last visited January 3, 2019).

M.J. Landrum , J.M Lee , M. Benson , and G. Brown et al., “ClinVar: Public Archive of Interpretations of Clinically Relevant Variants,” Nucleic Acids Research 4, no. 44 (Database issue, 2016): D862–868, available at <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4702865/> (last visited January 3, 2019).

See, e.g., B.M. Knoppers and Y. Joly , “Introduction: The Why and Whither of Genomic Data Sharing,” Human Genetics 137 (2018): 569-574, available at <https://link.springer.com/article/10.1007/s00439-018-1923-y> (last visited January 3, 2019).

Deverka, supra note 1.

A.L. McGuire , M.A. Majumder , A.G. Villanueva , and J. Bardill et al., “Importance of Participant-Centricity and Trust for a Sustainable Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 12-20.

See Villanueva, supra note 2.

A.G. Villanueva , R. Cook-Deegan , J.O. Robinson , and A.L. McGuire et al., “Genomic Data-Sharing Practices,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 31-40.

J.M. Bollinger , P.D. Zuk , M.A. Majumder , and E. Versalovic et al., “What Is a Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 41-50.

M.A. Majumder , J.M. Bollinger , A. G. Villanueva , P.A. Deverka , and B.A. Koenig , “The Role of Participants in a Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 51-61.

A.L. McGuire , J. Roberts , S. Aas , and B.J. Evans , “Who Owns the Data in a Medical Information Commons?” Journal of Law, Medicine & Ethics, 47, no. 1 (2019): 62-69.

P.A. Deverka , D. Gilmore , J. Richmond , and Z. Smith et al., “Hopeful and Concerned: Public Input on Building a Trustworthy Medical Information Commons,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 70-87.

See Bollinger, supra note 3.

T. Bubela , S.K. Genuis , N.Z. Janjua , and M. Krajden et al., “Medical Information Commons to Support Learning Health-care Systems: Examples from Canada,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 97-105.

M. Phillips and B.M. Knoppers , “Whose Commons? Data Protection as a Legal Limit of Open Science,” Journal of Law, Medicine & Ethics 47, no. 1 (2019): 106-111.