Ethics, Privacy, etc. Peter Szolovits 6.872/HST.950
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1 Ethics, Privacy, etc. Peter Szolovits 6.872/HST.950
2 Treatment of Human Subjects:The Belmont Report 1979 Ethical Principles and Guidelines for the Protection of Human Subjects of Research Balancing (societal) benefits vs. (individual) risks History of abuses Nazi experiments Nuremberg code Tuskegee syphilis study
3 Nazi Medical Experiments Freezing / Hypothermia Genetics Infectious Diseases Interrogation and Torture Killing / Genocide High Altitude Pharmacological Sterilization Surgery Traumatic Injuries A cold water immersion experiment at Dachau concentration camp presided over by Professor Ernst Holzlöhner (left) and Dr. Sigmund Rascher (right). The subject is wearing an experimental Luftwaffe garment unknown. All rights reserved. This content is excluded from our Creative Commons license. For more information, see
4 Tuskegee Syphilis Experiment experiment to study natural progression of disease 399 African-American sharecroppers w/ syphilis failed to treat even after penicillin was shown to be an effective treatment in 1940 s Public domain image from Wikimedia Commons.
5 Practice & Research The term practice refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The term research designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge. Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.... if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. From the Belmont Report
6 Basic Ethical Principles Respect for Persons Beneficence Justice From the Belmont Report
7 Respect for Persons Each person is an autonomous agent, capable of deliberation about personal goals and of acting under the direction of such deliberation Persons with diminished autonomy are entitled to protection: e.g., children, physically or mentally disabled, prisoners. Requires Informed Consent Adequate information Voluntary participation From the Belmont Report
8 (Informed Consent) Study involves research, purpose of research, duration, procedures, what is experimental? Foreseeable risks and discomforts Possible benefits to participants or others Alternative procedures that might be beneficial How confidentiality will be maintained For research involving more than minimal risk, what compensations and treatments may be available, and where to get further information Participation is voluntary; no penalty for refusal
9 Beneficence Do no harm one should not injure one person regardless of the benefits that might come to others minimize risk to participants Maximize possible benefits to society but, research subjects may not benefit directly Some tradeoffs are unavoidable From the Belmont Report
10 Justice Varied views of equal treatment equal share individual need individual effort societal contribution merit Select participants fairly Distribute benefits fairly From the Belmont Report
11 Enforcement: The Common Rule Applies to all US Government funded projects involving human subjects Institutional Review Boards (IRB) review and must approve all such proposed research; responsible to protect subjects yearly review of research protocols, informed consent, training of researchers, etc. Criteria of Belmont Report. expedited review for research involving no more than minimal risk ; consent may be waived exemptions for educational research, food quality research, and retrospective research on public or de-identified data IRB s also responsible for protection of confidentiality MIT s IRB is the Committee on Use of Humans as Experimental Subjects (COUHES)
12 Privacy vs. privacy
13 Protecting What? Privacy Individual s desire to limit disclosure of personal information Confidentiality Information sharing in a controlled manner Security Protecting information against accident, disaster, theft, alteration, sabotage, denial of service, Against what? Evil hackers Malicious insiders Stupidity Information Warfare 13
14 Privacy Right to be let alone; e.g.: snooping on Dan Quayle by J. Rothfeder outing of Arthur Ashe (HIV), Henry Hyde (adultery) celebrity medical problems (Tammy Wynette, Nicole Simpson) applies mostly to known individuals 14
15 Privacy in obscurity Right to remain unknown Correlation among pervasive databases: census marketing health Images by MIT OpenCourseWare. 15
16 Confidentiality Use and sharing of information by multiple users at many institutions Should be controlled by coherent policy Enforced by appropriate technology E.g., who may use results of your life insurance physical exam, for what purposes? 16
17 Legitimate Concerns (some may be ameliorated by ACA) Difficulty getting insurance Individual insurers may deny you coverage based on your medical history if it includes: Use of prescription drugs to treat anxiety, depression or a physical condition, including Ativan, Klonipin, Paxil, Prozac, Serzone, Zoloft, Xanax and Wellbutrin. Counseling for anxiety, depression, grief or an eating or sleep disorder. Even if you briefly sought counseling as a way to cope with the Sept. 11 terrorist attacks, you could be denied individual health insurance, according to researchers with Georgetown's Health Privacy Project. (MSN, March 9, 2004) Medical Information Bureau Data on all applicants for private life insurance in past 7 years 17
18 Additional Legitimate Concerns When employer pays insurance premiums, you may lose your job Self-insured companies Small employers facing experience rated policies Non-employment discrimination based on health Adoption Politics Social stigma 18
19 Employer s Clinic & Wellness program Patient s Employer Care Provider (physician, hospital Clinical Laboratory Consulting Physician State Bureau of Vital Statistics Patient Managed Care Organization Medical Researcher Life Insurance Company Accrediting Organization Retail Pharmacy Health Insurance Company Spouse s Employer Medical Information Bureau Lawyer in malpractice case Pharmacy Benefits Manager long term repository, patient-identified data short term repository, patient-identified data flow of patient-identified medical information flow of non-identifiable medical information temporary access, patient-identified data long term repository, non-patient-identified data temporary access, non-patient-identified data
20 Security Integrity of data No unauthorized modifications No dropped bits Availability Natural disaster Adversary attack Inadequacy of backup, fail-over Enforcement of confidentiality policies
21 De-Identification
22 Identifiable HIPAA: Name, address, phone number, fax number, address, URL, IP address, social security number, medical record n., health plan n., account n., certificate/license n., vehicle id, device id, biometric id, full-face photo, date of birth, zip code, gender, race, profession any other unique identifying number, characteristic, or code actual knowledge that the information could be used to identify Patterns of doctor visits, immunizations, etc. identifiable by inference depends on knowledge and abilities of data user Small bin sizes lead to identifiability Aggregate data into larger bins dob => age 3 digits of zip code 22
23 Sweeney s Cambridge 1997 Cambridge, MA voting list on 54,805 voters Name, address, ZIP, birth date, gender, Combinations that uniquely identify: Birth date (mm/dd/yy)12% BD + gender 29% BD + 5-digit ZIP 69% BD + 9-digit ZIP 97% Unique individuals Kid in a retirement community Black woman resident in Provincetown 23
24 Problem of other information Governor Weld s data found in Mass de-identified dataset Dates you visited a health care provider (over a lifetime) are probably unique Can be used to re-identify you if someone has both de-identified data and other data that link to identifiers Genetics makes this immensely more problematic Think Gattaca 24
25 Danger of Re-identification 25 Figure by Sweeney, Latanya. "Computational disclosure control: A primer on data privacy protection." Massachusetts Institute of Technology, 2001.
26 Protection via generalization 26 Figure by Sweeney, Latanya. "Computational disclosure control: A primer on data privacy protection." Massachusetts Institute of Technology, 2001.
27 Computational Disclosure Control Make sure data cannot be traced back to a set of size < n Generalization Suppression of unique combinations Account for leakage from what has been suppressed; e.g., backcalculating from aggregate statistics How to estimate external information? Every release becomes more external info. 27
28 Methods of Generalization/ Suppression Underlying problem (find minimal generalization/suppression to achieve a level of anonymity) is NP-hard (Vinterbo) Mainly heuristic search over space of possible generalizations/suppressions Scrub, Datafly, µ-argus (Netherlands), k-similar Lasko: spectral anonymization Build a model of data that captures the n-th order statistics of the distribution Synthesize fake patients from that distribution 28
29 MIT OpenCourseWare HST.950J / Biomedical Computing Fall 2010 For information about citing these materials or our Terms of Use, visit:
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