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The prestigious Institute of Medicine is in the process of crafting a document entitled “Strategies for Responsible Sharing of Clinical Trial Data.”367

Citizen Science: The Law and Ethics of Public Access to Medical Big Data

(2014)

Cited by: 2|Views395
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Abstract

Patient-related medical information is becoming increasingly available on the Internet, spurred by government open data policies and private sector data sharing initiatives. Websites such as HealthData.gov, GenBank, and PatientsLikeMe allow members of the public to access a wealth of health information. As the medical information terrain ...More

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Data:

Introduction
  • On May 9, 2013, President Barack Obama issued an executive order entitled “Making Open and Machine Readable the New Default for Government Information.”[1] The Order directed that, to the extent permitted by law, the government must release its data to the public in forms that are easy to find, access, and use.

    Health information drawn from patient records is among the most useful but sensitive types of data that are becoming commonly available to the public pursuant to President Obama’s policy and other public and private initiatives that will be discussed in this Article.
Highlights
  • On May 9, 2013, President Barack Obama issued an executive order entitled “Making Open and Machine Readable the New Default for Government Information.”[1] The Order directed that, to the extent permitted by law, the government must release its data to the public in forms that are easy to find, access, and use
  • Health information drawn from patient records is among the most useful but sensitive types of data that are becoming commonly available to the public pursuant to President Obama’s policy and other public and private initiatives that will be discussed in this Article
  • In the alternative, according to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, deidentification is achieved if the following eighteen identifiers are removed: (A) Names; (B) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000; (C) All elements of dates for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over and all elements of dates indicative of such age, except that such ages and elements may be aggregated into a single category of age or older; (D) Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses; (G) Social security numbers; (H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K) Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators (URLs); (O) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger and voice prints; (Q) Full face photographic images and any comparable images; and
  • The medical and scientific communities are rapidly adopting a culture of data sharing, and the expansion of open data practices is widely perceived as inevitable.[366]
  • The prestigious Institute of Medicine is in the process of crafting a document entitled “Strategies for Responsible Sharing of Clinical Trial Data.”[367]
Results
  • The HIPAA Privacy Rule,[139] the Privacy Act,[140] and numerous state privacy laws govern the disclosure of medical records.[141] the laws and regulations do not cover all data holders who make medical information publicly available.[142] In addition, public-use data is most often presented in de-identified form[143] and is exempt from the disclosure restrictions established in these laws and regulations.[144] even with thorough deidentification, at least a small risk of re-identification remains.
  • Analysis of state law is beyond the scope of this Article.[153] In general, state laws are varied and inconsistent, often providing piecemeal protection for some types of data but not others.[154] like the HIPAA Privacy Rule and the Privacy Act, states typically allow disclosure of de-identified health information without patient authorization.[155] most of the public-use data resources contemplated in this Article would not be governed by state law.
Conclusion
  • In the alternative, according to the HIPAA Privacy Rule, deidentification is achieved if the following eighteen identifiers are removed: (A) Names; (B) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000; (C) All elements of dates for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over and all elements of dates indicative of such age, except that such ages and elements may be aggregated into a single category of age or older; (D) Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses; (G) Social security numbers; (H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K) Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators (URLs); (O) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger and voice prints; (Q) Full face photographic images and any comparable images; and
Funding
  • NIH appropriations peaked at $36.4 billion in fiscal year 2010 thanks to funding from the American Recovery and Reinvestment Act, but they declined to $29.9 billion by fiscal year 2014
  • Crowdfunding has become so popular that it is being used not only by enterprising individuals and companies but also by several universities, such as the University of Virginia and Tulane, that are seeking to compensate for the dearth of funding from traditional sources
  • Karen Kaplan, Crowd-Funding: Cash on Demand, 497 NATURE 147, 148 (2013). 248
Study subjects and analysis
data sets: 1000
Federal Government Data at HealthData.gov. HealthData.gov, launched in 2011, is a Department of Health and Human Services website that makes over 1000 data sets available to researchers, entrepreneurs, and the public free of charge.24. It predates Executive Order 13,642 by two years and establishes a home for the federal government’s open data

complete genomes: 900
The data are free, and GenBank places no restriction on their use.54. According to scientists at the National Center for Biotechnology Information, GenBank contains “over 900 complete genomes, including the draft human genome, and some 95,000 species.”[55] Leading journals. 47

Dutch DIY biologists: 3
Citizen scientists have proven themselves to be capable inventors whose contributions aid many people. For example, three Dutch DIY biologists created Amplino, an inexpensive diagnostic system that can be used in developing countries to detect malaria with a single drop of blood in less than forty minutes.84. Likewise, Katherine Aull, a graduate of the Massachusetts Institute of Technology whose father suffered from

people: 3000
The gold standard of medical research has traditionally been randomized, controlled clinical trials.105. Phase 3 clinical trials, conducted as the final step before approval of a drug, cost an average of $20 million, involve 300 to 3000 people, and last one to four years.106. These experimental studies are conducted through “the collection of data on a process when there is some manipulation of variables that are assumed to affect the outcome of a process, keeping other variables constant as far as possible.”[107] Thus, investigators might design a clinical trial to compare two drugs for a particular ailment or to compare a drug to a placebo

donors: 390
Ethan O. Perlstein, Anatomy of the Crowd4Discovery Crowdfunding Campaign, 2 SPRINGERPLUS 560, 561 (2013), http://www.springerplus.com/content/pdf/2193-1801-2 -560.pdf (reporting that the authors raised $25,460 from 390 donors in 15 countries for a pharmacological research project); Joe Palca, Scientists Get Research Donations from Crowd Funding, NPR (Mar. 15, 2013), http://www.npr.org/2013/02/14/171975368/scientist -gets-research-donations-from-crowdfunding (reporting that UBiome and American Gut together raised over $600,000 for projects designed to discover how microbiomes (tiny organisms that reside in the human body) influence health when donors were promised an analysis of the bacteria in their own digestive tracts). The Internet offers a large number of platforms for crowdfunding, including the aptly named Kickstarter, Experiment, and Indiegogo, among others

people: 20000
Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, U.S DEP’T OF HEALTH & HUMAN SERVS. (Nov. 26, 2012), http://www.hhs.gov/ ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html. In the alternative, according to the HIPAA Privacy Rule, deidentification is achieved if the following eighteen identifiers are removed: (A) Names; (B) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000; (C) All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; (D) Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses; (G) Social security numbers; (H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K) Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators (URLs); (O) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger and voice prints; (Q) Full face photographic images and any comparable images; and. #guidancedetermination (noting that techniques such as suppression and generalization are often used in combination)

Chinese adults aged 60 to 105: 3018
Some researchers have in fact focused on particular ethnic sub-groups and concluded that they have more health problems than others. A prime example is the PINE Study, for which investigators interviewed 3,018 Chinese adults aged 60 to 105 who lived in the Chicago area between 2011 and 2013.205 The study concluded that “Chinese older adults experience disproportionate health disparities,” suffering from significant physical, psychological, financial, and social challenges.206. Though this was far from the study’s intention, readers of the report may think twice about hiring people of Chinese ancestry who are sixty or older

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