Comparative effectiveness research and big data: Balancing potential with legal and ethical considerations

Journal of Comparative Effectiveness Research

Volumn 4, Issue 1, 2015, Pages 61-74

  Gray, Elizabeth Alexandra ^a   Thorpe, Jane Hyatt ^a  

^a GEORGE WASHINGTON UNIVERSITY   (United States)

Author keywords

big data; comparative effectiveness research; ethics; health information; health information exchange; legal; privacy; research; security

Indexed keywords

ACCESS TO INFORMATION; AUTHORITY; BILLING AND CLAIMS; CLINICAL EFFECTIVENESS; CLINICAL RESEARCH; COMPARATIVE EFFECTIVENESS; DATA BASE; ELECTRONIC MEDICAL RECORD; FINANCIAL MANAGEMENT; HEALTH CARE ACCESS; HEALTH CARE DELIVERY; HEALTH CARE PLANNING; HEALTH CARE QUALITY; HUMAN; INFORMED CONSENT; LAW; MEDICAID; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL INFORMATION SYSTEM; MEDICARE; MEDICOLEGAL ASPECT; PATIENT AUTONOMY; REVIEW; DATA MINING; ETHICS; LEGISLATION AND JURISPRUDENCE; METHODOLOGY; PATIENT PARTICIPATION; RESEARCH ETHICS; TOTAL QUALITY MANAGEMENT;

COMPARATIVE EFFECTIVENESS RESEARCH; DATA MINING; ETHICS, RESEARCH; HUMANS; PATIENT PARTICIPATION; QUALITY IMPROVEMENT; RESEARCH DESIGN;

EID: 84920847860     PISSN: 20426305     EISSN: 20426313     Source Type: Journal    
DOI: 10.2217/cer.14.51     Document Type: Review

References (68)

1. Howles T. Data, data quality, and ethical use. Software Quality Professional 16(2), 4-12 (2014).
2. Murphy M, Barton J. From a sea of data to actionable insights: big data and what it means for lawyers. Intellectual Property & Technology Law Journal 26(3), 8-17,11 (2014).
3. Concato J, Peduzzi P, Huang GD, O'Leary TJ, Kupersmith J. Comparative effectiveness research: what kind of studies do we need? J. Investig. Med. 58(6), 764-769 (2010).
4. Giuliano KK, Ferguson M, Silfen E. Medical technology innovation and the importance of comparative effectiveness research. J. Med. Marketing 12(1), 55-66 (2012).
5. Jensen P, Jensen L, Brunak S. Mining electronic health records: towards better research applications and clinical care. Nat. Rev. Genet. 13(6), 395-405 (2012).
6. Pearson J, Brownstein C, Brownstein J. Potential for electronic health records and online social networking to redefine medical research. Clin. Chem. 57(2), 196-204 (2011).
7. Hoffman S, Podgurski A. The use and misuse of biomedical data: is bigger really better? Am. J. Law. Med. 39(4), 497-538 (2013).
8. US Food and Drug Administration. FDA's Sentinel Initiative-Background (2010). www.fda.gov
9. US Food and Drug Administration. Welcome to Mini-Sentinel http://minisentinel.org
10. National Human Genome Research Institute, National Institutes of Health. Electronic Medical Records and Genomics (eMERGE) Network (2014). www.genome.gov
11. Patient-Centered Outcomes Research Institute (PCORI). Statement of PCORI Executive Director Joe Selby, MD, MPH, Following Center for American Progress Event on Comparative Effectiveness Research (2014). www.pcori.org
12. Patient-Centered Outcomes Research Institute (PCORI). PCORnet: The National Patient-Centered Clinical Research Network (2013). www.pcori.org
13. Chassin MR. Improving the quality of health care: what's taking so long? Health Aff. (Millwood) 32(10) 1761-1765 (2013).
14. Roszell S. Research in quality improvement: a safety checklist creates an uproar. J. Nurs. Law 13(1), 19-24 (2009).
15. Weitner M, Garvin T. Predictive analytics in safety and operational risk management. IBM Corporation Somers, NY (2012). www-01.ibm.com
16. Marmor YN, Rohleder TR, Cook DJ, Huschka TR, Thompson JE. Recovery bed planning in cardiovascular surgery: a simulation case study. Health Care Manag. Sci. 16(4), 314-327 (2013).
17. Eddy D. Evidence-based medicine: a unified approach. Health Aff. (Millwood) 24(1), 9-17 (2005).
18. Stewart W, Shah N, Selna M, Paulus R, Walker J. Bridging the inferential gap: the electronic health record and clinical evidence. Health Aff. (Milwood) 26(2), w181-w191 (2007).
19. Robert Wood Johnson Foundation Commission to Build a Healthier America. Beyond health care: New directions for a healthier America. (2009). www.rwjf.org
20. Fox B. Using big data for big impact. Health Manag. Technol. 32(11), 16 (2011).
21. Edwards JE, Halawi LA. Analysis of variation in HIT privacy & security laws. Cambridge Business Review 18(1), 240-248 (2011).
22. HIPAA General Administrative Requirements. Applicability. 45 CFR 160.103 (2013).
23. HIPAA Privacy Rule. Uses and disclosures of protected health information. 45 CFR 164.502 (2013).
24. HIPAA Privacy Rule. Other requirements relating to uses and disclosures of protected health information. 45 CFR 164.514 (2013).
25. HIPAA Privacy Rule. Uses and disclosures to carry out treatment, payment, or health care operations. 45 CFR 164.506 (2013).
26. HIPAA Privacy Rule Definitions 45 CFR 164.501 (2013).
27. HIPAA Privacy Rule. Uses and disclosures for which an authorization or opportunity to agree or object is not required. 45 CFR 164.512 (2013).
28. HIPAA Privacy Rule. Uses and disclosures for which an authorization is required. 45 CFR 164.508 (2013).
29. HIPAA Security Rule. Security Standards for the Protection of Electronic Protected Health Information. 45 CFR Part 164, Subpart C (2013).
30. HIPAA Breach Notification Rule. Notification in the Case of Breach of Unsecured Protected Health Information. 45 CFR Part 164, Subpart D (2013).
31. The Common Rule. To what does this policy apply? 45 CFR 46.101 (2013).
32. The Common Rule. Definitions. 45 46.102 (2013).
33. The Common Rule. General requirements for informed consent. 45 CFR 46.116 (2013).
34. The Common Rule. Documentation of informed consent. 45 CFR 46.117 (2013).
35. US Department of Health and Human Services. Advanced Notice of Proposed Rulemaking: Advance Notice of Proposed Rulemaking: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. 76 Fed. Reg. 44512, (2011).
36. The Genetic Information Nondisclosure Act (GINA). Pub. L. No. 110-233, 2000ff, 122 Stat. 881 (2008).
37. The Privacy Act. Pub. L. No. 93-579, 552a, 88 Stat. 1896 (1974).
38. The Freedom of Information Act (FOIA). Pub. L. No. 89-487, 552, 80 Stat. 250 (1967).
39. Fla. Med. Ass'n v. US Dep't of Health, Educ., & Welfare. 947 F.Supp.2d 1325 (M.D. Fla. 2013).
40. US Department of Health and Human Services. Notice: modified policy on disclosure of amounts paid to individual physicians under the Medicare program. 79 Fed. Reg. 3205 (2014).
41. Centers for Medicare & Medicaid Services. Medicare provider utilization and payment data: physician and other supplier. (2014). www.cms.gov
42. US Department of Health and Human Services. Final rule: Medicare program; contract year 2015 policy and technical changes to the Medicare Advantage and the Medicare prescription drug benefit programs. 79 Fed. Reg. 29843 (2014).
43. Confidentiality of Alcohol and Drug Abuse Patient Records (Part 2). 42 CFR Part 2, (2013).
44. Legal Barriers Project. Health Information & the Law. Deparment of Health Policy, Milken Institute School of Public Health at the George Washington University, Robert Wood Johnson Foundation (2012). www.healthinfolaw.org
45. Pritts J, Lewis S, Jacobson R, Lucia K, Kayne K. Privacy and security solutions for interoperable health information exchange: report on state law requirements for patient permission to disclose health information. US Department of Health and Human Services. (2009). www.healthit.gov
46. Centers for Disease Control and Prevention. State HIV Laws. (2013). www.cdc.gov
47. Pritts JL. The importance and value of protecting the privacy of health information: the roles of the HIPAA Privacy Rule and the Common Rule in health research. National Academy of Sciences. (2008). www.iom.edu
48. Sorrell v. IMS Health, Inc. 131 US 2653 (2011).
49. Harrington SE. Incentivizing comparative effectiveness research. Ewing Marion Kauffman Foundation, Kansas City, MO (2011). www.kauffman.org
50. Mcgraw D, Dempsey JX, Harris L, Goldman J. Privacy as an enabler, not an impediment: building trust into health information exchange. Health Aff. (Millwood) 28(2), 416-427 (2009).
51. Tene O, Polonetsky J. Big data for all: privacy and user control in the age of analytics. Northwestern J. of Technology and Intellectual Property 11(5), 34 (2013).
52. Vayena E, Mastroiann A, Kahn J. Ethical issues in health research with novel online sources. Am. J. Public Heath 102(12), 2225-2230 (2012).
53. El-Emam K, Jonker E, Arbuckle L, Malin B. A systematic review of re-identification attacks on health data. PLoS 6(12), e28071 (2011).
54. Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP chair letter to HHS Secretary on HIPAA: appendix F. (2004). www.hhs.gov
55. Cate FH. Protecting privacy in health research: The limits of individual choice. Cal. Law Rev. 98(6), 1765-1803 (2010).
56. Peddicord D, Waldo AB, Boutin M, Grande T, Gutierrez L, Jr. A proposal to protect privacy of health information while accelerating comparative effectiveness research. Health Aff. (Millwood) 29(11), 2082-2090 (2010). 31(3), 429-433 (2003).
57. Marti A. Addressing the challenges of HIPAA compliance in research, part II. J. Health Care Compliance 7(2), 59-64 (2005).
58. Crook MA. The risks of absolute medical confidentiality. Sci. Eng. Ethics. 19(1), 107-122 (2013).
59. Chan EM, Lam PE, Mitchell JC. Understanding the challenges with medical data segmentation for privacy. Stanford University (2013). www-cs-students.stanford.edu
60. Angst CM. Protect My Privacy or Support the Common-Good? Ethical Questions About Electronic Health Information Exchanges. Journal of Business Ethics 90(S2), 169-178 (2010).
61. Hodge JG, Gostin LO, Jacobson PD. Legal issues concerning electronic health information: privacy, quality, and liability. JAMA 282(15), 1466-1471 (1999).
62. Duke Center for Health Informatics. Secondary Data Use (n.d.). www.dchi.duke.edu
63. El-Emam K, Arbuckle L, Koru G, Eze B, Gaudette L, Neri E et al. De-identification methods for open health data: the case of the Heritage Health Prize claims dataset. J. Med. Internet Res. 14(1), e33 (2012).
64. Hoffman S, Podgurski A. Balancing privacy, autonomy, and scientific needs in electronic health records research. Southern Methodist University Law Review 65(85), 69 (2012).
65. Diamond CC, Mostashari F, Shirky C. Collecting and sharing data for population health: A new paradigm. Health Aff. (Millwood) 28(2), 454-466 (2009).
66. Croll A, Voytek B. Big Data is Our Generation's Civil Rights Issue, and We Don't Know It. In: Big Data Now (2012 Edition). O'Reilly Media, Inc., Sebastopol, CA (2012).
67. Rodwin MA. Patient Data: Property, Privacy & the Public Interest. Am. J. Law Med. 36(4), 586-618 (2010).
68. Miller FG. Research on medical records without informed consent. J. Law Med. Ethics 36(3), 560 (2008).