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Confidentiality, Privacy and Security C. William Hanson M.D. Professor of Anesthesiology and Critical Care CS Department Princeton University

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Presentation on theme: "Confidentiality, Privacy and Security C. William Hanson M.D. Professor of Anesthesiology and Critical Care CS Department Princeton University"— Presentation transcript:

1 Confidentiality, Privacy and Security C. William Hanson M.D. Professor of Anesthesiology and Critical Care CS Department Princeton University

2 Privacy The desire of a person to control the disclosure of personal health information

3 Confidentiality The ability of a person to control release of personal health information to a care provider or information custodian under an agreement that limits further release of that information

4 Security Protection of privacy and confidentiality through policies, procedures and safeguards.

5 Why do they matter? Ethically, privacy and confidentiality are considered to be rights (in our culture) Information revealed may result in harm to interests of the individual The provision of those rights tends to ensure that the information is accurate and complete Accurate and complete information from individuals benefits society in limiting spread of diseases to society (i.e. HIV)

6 Why do they matter? The preservation of confidentiality assists research which in turn assists patients

7 Users of health information Patient –Historical information for current and future care –Insurance claims MD’s –Patient’s medical needs –Documentation –Interface with other providers –Billing

8 Users Health insurance company –Claims processing –Approve consultation requests Laboratory –Process specimens –Results reporting –Billing

9 Users Pharmacy –Fill prescription –Billing Hospital –Care provision –Record of services –Billing –Vital statistics –Regulatory agencies

10 Users State bureau –Birth statistics –Epidemiology Accrediting organization –Hospital review Employer –Request claims data –Review claims for $ reduction –Benefits package adjustments

11 Users Life insurance companies –Process applications –Process claims –Risk assessment Medical information bureau –Fraud reduction for life insurance companies Managed care company –Process claims –Evaluate MD’s

12 Users Lawyers –Adherence to standard of practice –Malpractice claims Researcher –Evaluate research program

13 Security Availability Accountability Perimeter definition Rule-limited access Comprehensibility and control

14 Privacy solutions Forbid the collection of data that might be misused Allow the collection of health information within a structure, but with rules and penalties for violation pertaining to collecting organizations Generate policies to which individual information handlers must adhere

15 Security controls Management controls –Program management/risk management Operational controls –Operated by people Technical controls –Operated by the computer system

16 Management controls Establishment of key security policies, i.e. policies pertaining to remote access –Program policy Definition, scope, roles and responsibilities of the computer security program –Issue specific policy Example: Y2K –System specific policy Who can access what functions where

17 Core security policies Confidentiality System access Virus protection Internet/intranet use Remote access Software code of ethics Backup and recovery Security training and awareness

18 Biometrics The scientific discipline of measuring relevant attributes of living individuals or populations to identify active properties or unique characteristics –Can be used to evaluate changes over time for medical monitoring or diagnosis –Can be used for security

19 Approaches to identification Token based simple security –House key, security card, transponder Knowledge based –SSN, password, PIN Two-factor –Card + PIN CardPIN IDAuthentication Access +

20 Approaches to identification Authoritative ID ID Authent- ication Policy Access Audit T F

21 Identification Certain and unambiguous –Deterministic Certain with small probability of error –Probabilistic Uncertain and ambiguous Biometric schemes are probabilistic

22 Probabilistic False acceptance rate (type I error) –Percentage of unauthorized attempts that will be accepted –Also relevant for medical studies False rejection rate (type II error) –Percentage of authorized attempts that will be rejected –Also relevant for medical studies Equal error rate –Intersection of the lowest FAR and FRR

23 Biometric ID Acquire the biometric ID –How do you ensure that you got the right guy Localize the attribute –Eliminate noise –Develop a template (reduced data set) Check for duplicates

24 Biometric applications Identification –Search the database to find out who the unknown is –Check entire file Authentication –Verify that the person is who he says he is –Check his file and match

25 Biometric identifiers Should be universal attribute Consistent – shouldn’t change over time Unique Permanent Inimitable (voice can be separated from the individual) Collectible – easy to gather the attribute Tamper resistant (Cheaply) comparable - template

26 Biometric technologies Fingerprint –Automated fingerprint ID systems (law enforcement) –Fingerprint recognition – derives template form features for ID –Validating temp and /or pulse –Optical vs. solid state (capacitance) –Low FAR and FRR

27 Fingerprint

28 Hand geometry Dimensions of fingers and location of joints unique Low FAR FRR

29 Retinal scan Very reliable More expensive than hand or fingerprint Extremely low FAR FRR

30 Retinal scan

31 Voice recognition Automatic speaker verification (ASV) vs. automatic speaker identification (ASI) –ASV = authentication in a two-factor scheme –ASI = who is speaker –Feature extraction and matching –Problems with disease/aging etc.

32 Iris scanning Less invasive than retinal scanning Technically challenging balancing optics, ambient light etc. Can be verified (live subject) by iris response to light

33 Face recognition/thermography Facial architecture and heat signature Relatively high FAR/FRR Useful in two factor scenarios

34 Hand vein Infrared scanning of the architecture of the hand vessels

35 Signature Architecture of the signature Dynamics of the signature (pressure and velocity)

36

37 Biometric identification issues Privacy, anonymity Legal issues not defined

38 Security: availability Ensures that accurate, up-to-date information is available when needed at appropriate places

39 Security: accountability Ensures that users are responsible for their access to and use of information based on a documented need and right to know

40 Security: perimeter definition Allows the system to control the boundaries of trusted access to an information system both physically and logically

41 Security: rule-limited access Enables access for personnel to only that information essential to the performance of their jobs and limits the real or perceived temptation to access information beyond a legitimate need

42 Security: comprehensibility and control Ensures that record owners, data stewards and patients can understand and have effective control over appropriate aspects of information confidentiality and access

43 Availability Backups with local and off-site copies of the data Secure housing and power sources for CPU even during disasters (when system availability may be crucial) Virus protection

44 Accountability Audit trails and warnings User –Authentication – unique ID process –Authorization – to perform set of actions, i.e. access only their own patients

45 Perimeter definition System knows users and how they are using the system –Define the boundaries of the system (i.e. within the firewall) Princeton-Penn-HUP –How do you permit/monitor off-site access –Modems? Tools –Cryptographic authentication

46 Perimeter definition Public key-private key –Encryption Privacy and confidentiality –Digital signatures Prescription signature –Content validation Message hasn’t been messed with –Nonrepudiation “I didn’t say that”

47 Role limited access Spheres of access –Patient list: patients one has a role in the care of –Content specific: billing clerk/billing info –Relevant data: researcher on heart disease shouldn’t be able to learn about HIV status

48 Taxonomy of organizational threats Motive –Health records have economic value to insurers, employers, journalists, enemy states etc. –Curiosity about the health status of friends, romantic interests, coworkers or celebrities –Clandestine observation of employees (GE) –Desire to gain advantage in contentious situations (divorce)

49 Resources Attackers may range from –Individuals –Small group (e.g. law firm) –Large group (e.g. insurer, employer) –Intelligence agency –Organized crime

50 Initial access Site access System authorization Data authorization Site Data System Worker Billing clerk Computer vendor MD, RN

51 Technical capability Aspiring attacker (limited skills) –Research target –Masquerade as an employee –Guess password –Dumpster diving –Become temporary employee

52 Technical capability Script runner –Acquire software from web-sites for automated attacks Accomplished attacker –Able to use scripted or unscripted (ad-hoc) attacks

53 Levels of threat Threat 1 –Insiders who make “innocent” mistakes and cause accidental disclosure –Elevator discussion, info left on screen, chart left in hallway etc. Threat 2 –Insiders who abuse their privileges

54 Threat Threat 3 –Insiders who access information inappropriately for spite or profit –London Times reported that anyone’s electronic record could be obtained for $300 Threat 4 –Unauthorized physical intruder –Fake labcoat

55 Threats Threat 5 – Vengeful employees or outsiders bent on destruction or degradation, e.g. deletion, system damage, DOS attacks –Latent problem

56 Countering threats Deterrence –Create sanctions –Depends on identification of bad actors Imposition of obstacles –Firewalls –Access controls –Costs, decreased efficiency, impediments to appropriate access

57 Countermeasures TypeSystemDataSiteThreatCounter 1YYYMistake Org and technical measures 2YYN/A Improper use of access privileges Authentication and auditing 3YNN/A Unauthorized for spite of money Authentication and auditing 4YNY Unauthorized physical intrusion Physical security and access control 5YNNTechnical breakin Authentication, access and crypto

58 Counter threat 1 Behavioral code Screen savers, automated logout ? Patient pseudonyms

59 Counter threat 2 Deterrence Sanctions Audit Encryption (user must obtain access keys)

60 Counter threat 3 Audit trails Sanctions appropriate to crime

61 Counter threat 4 Deterrence Strong technical measures (surveillance tapes) Strong identification and authentication measures

62 Counter threat 5 Obstacles Firewalls

63 Issues with countermeasures Internet interface Legal and national jurisdiction Best balance is relatively free internal environment with strong boundaries –Requires strong ID/auth

64 Recommendations Individual user ID and authentication –Automated logout –Password discipline Access controls –Role limited –Role definitions Cardiologist vs. MD Audit trails

65 Recommendations Physical security and disaster recovery –Location of terminals –Handling of paper printouts Remote access points –VPN’s –Encrypted passwords –Dial-ins

66 Recommendations External communications –Encrypt all patient related data over publicly available networks Software discipline –Virus checking programs System assessment –Run scripted attacks against one’s own system

67 Recommendations Develop security and confidentiality policies –Publish –Committees –ISO’s –Sanctions Patient access to audit logs –Who saw my record and why

68 Future recommendations Strong authentication –Token based authentication (two factor) Enterprise wide authentication –One-time login to authorized systems Access validation –Masking Expanded audit trails Electronic signatures

69 Universal patient identifier Methodology should have an explicit framework specifying linkages that violate patient privacy Facilitate the identification of parties that make improper linkages Unidirectional – should facilitate helpful linkages of health records but prevents identification of patient from health records or the identifier

70 Implications of the Health Insurance Portability and Accountability Act of 1996 Mark Weiner, M.D. Assistant Professor of Medicine University of Pennsylvania Computer Science 495 Special Topics in CS: Medical Informatics February 21, 2002

71

72 What is HIPAA Health Insurance Portability and Accountability Act of 1996 proposed by Sen. Edward Kennedy (D-MA) and Nancy Kasselbaum (R-KS) –Focused on issues involving obtaining new insurance at new job with pre- existing conditions protection from fraud administrative simplification –Electronic transmittal of data for billing purposes –Privacy issues related to transmission of clinical data

73 What Information is covered under HIPAA Personal Health Information (PHI) –Anything that can potentially identify an individual Name Zip code of more than 3 digits Dates (except year) Telephone and fax numbers addresses Social Security Numbers Medical Record Numbers Health Plan Numbers License numbers

74 Privacy vs. Security Privacy –Administrative mechanisms that govern the appropriate use and access to data Not all hospital employees need to know everything about a patient Security –Technical mechanisms to ensure privacy don’t have a fax machine that receives personal information in a public place Encrypt electronic communications

75 Privacy before HIPAA 4th Amendment (…secure in their persons, houses, papers and effects against unreasonable searches and seizures…) Fair Credit Reporting Act (1970) Privacy Act (1974) Family Educational Rights and Privacy Act (1974) Right to Financial Privacy Act (1978) Privacy Protection Act (1980) Electronic Communications Privacy Act (1986) Video Privacy Protection Act (1988) Employee Polygraph Protection Act (1988) Telephone Consumer Protection Act (1991) Driver’s Privacy Protection Act (1994) Telecommunications Act (1996) Children’s Online Privacy Protection Act (1998) Identity Theft and Assumption Deterrence Act (1998) Gramm-Leach-Bliley Act (1999)

76 Gaps in privacy protection Most of the preceding laws protect aspects of personal information (mostly financial), but not Health Information Inconsistent State laws exist for protection of information regarding certain health conditions -- HIV, Mental Illness, Cancer

77 Concern about loss of Privacy 1998 National Survey –33% concerned about the amount of information being requested from various sources –55% VERY concerned 1995 Survey –80% agreed with statement that they had lost all control of their medical information

78 Concern About Loss of Privacy 1999 Survey –What issues concerned them the most in the coming century? 29% listed “Loss of Personal Privacy” as 1st or 2nd concern 23% or less selected terrorism, world war, global warming

79 Concern About Loss of Privacy Internet usage (1999 survey) –82% have used a computer –64% have used the internet –58% have sent –59% worry that an unauthorized person will gain access to their information –75% of people visiting health sites are concerned that information is being shared

80 Concern About Loss of Privacy Electronic Medical Records/Data Banks –75% express concern about insurance companies putting information about them in a database accessible by others –35% of Fortune 500 companies look at medical records before making hiring or promotional decisions

81 Concern About Loss of Privacy Genetic information –85% concerned that insurers and employers may gain access to personal genetic information –63% would not take genetic screening tests if the information was going to be shared with insurers and employers –32% of eligible people refused to have genetic testing for breast cancer risk because of privacy concerns

82 Are These Privacy Concerns Unfounded? A Michigan based Health System accidentally posted medical records of thousands of patients on the Internet A Utah-based pharmacy benefits management company used patient data to solicit business for its parent company -- a drug store

83 Are These Privacy Concerns Unfounded? Health Insurance Claims forms blew out of a truck on its way to a recycling center A patient in a Boston-area hospital discovered that her medical record had been read by more than 200 hospital employees A Nevada woman purchased a used computer that still had prescription records from the pharmacy that formerly owned the computer

84 Are These Privacy Concerns Unfounded? Johnson and Johnson markets a list of 5 million names and addresses of elderly incontinent women A few weeks after undergoing a blood test, an Orlando woman received a letter from a drug company promoting their treatment for high cholesterol

85 Are These Privacy Concerns Unfounded? A banker who also sat on a county health board identified people with cancer and called in their mortgages! A physician diagnosed with AIDS had his surgical privileges suspended (Medical Center of Princeton) A newspaper published the history of psychiatric treatment and suicide attempt of congressional candidate

86 Why does electronic communication increase privacy concerns ? Problems with paper charts - Messy, difficult to find, one physical copy - all make it harder to acquire and disseminate information Electronic documents can be intentionally or unintentionally transmitted to thousands of people at once

87 What is HIPAA designed to do? Give patients more control over use of data Set boundaries on uses and disclosures of data Establish safeguards to protect data Establish accountability for privacy breaches Balance privacy with social responsibility

88 HIPAA Timeline HIPAA Signed into law –Privacy regulations not specified –Congress was to enact laws and policy regarding privacy by 1999 –If Congress failed to develop standards, task would fall to Department of Health and Human Services (DHHS) DHHS becomes responsible for developing privacy regulations

89 HIPAA Timeline DHHS proposes privacy standards and opens them up for public comment DHHS receives 50,000 comments on regulations December DHHS publishes “Final Privacy Rule” February Enactment of Final Rule delayed because of “administrative difficulties.” Further public comment requested

90 HIPAA Timeline April Privacy Rule implementation phase begins April Deadline for covered entities to complete implementation plan

91 HIPAA Stipulations for Using and Releasing Information Notification Consent Authorization

92 HIPAA Stipulations for Using and Releasing Information Notification –Informing patients in simple language regarding the manner in which their data is handled

93 HIPAA Stipulations for Using and Releasing Information Consent –one time, general agreement to use the patient’s information in treatment. For payment, or for “healthcare operations” –Lasts indefinitely, necessary for treatment –Sharing information between primary care physician and consulting specialist –Regulations allows provision of care to be conditioned on patient’s consent to use information for payment purposes.

94 HIPAA Stipulations for Using and Releasing Information Authorization –limited in time and scope –Non-routine purpose –Example : Patient is actively participating in a research protocol and personal health information will be shared with a clinical service or university

95 Health-related activities covered by HIPAA Health Care Billing Marketing Fund Raising Research

96 HIPAA In Health Care Consent to release information to insurance carriers for billing purposes Primary and consulting physicians given full access to record for treatment purposes Hospital Staff provided “minimum necessary” information to conduct business Laboratories and Radiology offices can use information for billing purposes Stipulations about auditing of who has seen/used what information

97 HIPAA In Health Care Fax machines Hospital information networks Physical security of computer hardware

98 Research under HIPAA Continues as before when appropriate informed consent is obtained from subjects. Special consideration necessary when using data without explicit consent of subjects –Few restrictions when using de-identified data on populations of patients (no names, SSNs, addresses; birthdates; populations must have substantial size) –Oversight required to use identifiable data

99 Research under HIPAA Patient consent NOT required with identifiable data when all of the following are true: –IRB approves protocol and use of data –use or disclosure of data presents minimal risk –will not affect privacy and welfare of individual –consent process impractical –research could not be conducted without information –plan exists to protect identifiers from improper use and disclosure –Data will not be reused for other purposes without authorization from IRB

100 HIPAA in Research Summary Little oversight needed for de-identified, population-based data IRB authorization required to access identifiable patient information Duty to inform patients regarding research uses of their data Audit trails of information access for research ??? Responsibilities when initiating patient contact based on knowledge of personal information

101 Accountability Civil penalties –Violation of standards will be subject penalties of $100 per violation, up to $25,000 per person, per year for each requirement or prohibition violated.

102 Accountability Federal criminal –up to $50,000 and one year in prison for obtaining or disclosing protected health information – up to $100,000 and up to five years in prison for obtaining protected health information under "false pretenses” –up to $250,000 and up to 10 years in prison for obtaining or disclosing protected health information with the intent to sell, transfer or use it for commercial advantage, personal gain or malicious harm.

103 Penn’s High Level Approach to HIPAA Identify organizational components and communication links relevant to Health Care –Define which components of health information can be transmitted among which the components –Set up secure communication strategy among components (intranets, firewalls, encryption)

104 University of Pennsylvania Health System 4 owned hospitals –Hospital of the University of Pennsylvania –Presbyterian Medical Center –Pennsylvania Hospital –Phoenixville Hospital 65 owned primary care ambulatory practices (Community Care Associates)

105 University of Pennsylvania Health System Owned by the University of Pennsylvania that also has other related health care entities –Nursing school –Dental School –Student Health Service –Counseling

106 The overlapping lines of communication “Health Care Component” University (Hybrid Entity) SOM SON CPUP CHOPVA St. Luke’sHoly RedeemerPenn Friends ORA (IRBs) Athletics Student Health Counseling Wharton LDI CTT School of Social Work WistarCancer Network Independent Medical Staffs – PAH, PMC, PHX Others SODM __ - Hybrid __ - ACEs __ - OHCAs CCAPHXPMCPAH HUP Covered Entity within Hybrid

107 Penn’s Approach to Research Data Use Research requires data! Not all research requires personal identifiers Personal identifiers are often necessary to validate and integrate data from different systems Identifiers are often necessary to conduct retrospective research

108 Penn has a Research Database Pennsylvania Integrated Clinical and Administrative Research Database The PICARD System }

109 Data Integration and Access IDX SMS Cerner Dept system Data Warehouse (Oracle on DEC Alpha DS20) Application Server (Apache) Web Clients MSAccess FTP Oracle Sql*Net8 HTML ODBC Oracle Tools

110 Available Data Ambulatory Data –Primary and subspecialty care data-- Jan May 2001 –Patient information Location Gender Race Birthdate Insurance carrier

111 Available Data Inpatient data –Patient information –Admission Detail for HUP and Presby Admission, DC dates, LOS Diagnoses Procedures for recent admissions Charges for procedures/room/medicine etc.

112 Available Data Laboratory –75 common chemistries, hematology and serology results since August, 1997 Cardiology testing –Stress test, cath, echo results Pharmacy –Limited population Pulmonary Function test data

113 Penn’s Approach to Research Data Use Minimal oversight –Information regarding a provider’s own patients –Determination of numbers of patients meeting specified criteria IRB approval –Release of Medical Record numbers for additional chart review IRB and “PAC” review –Required before patient contact initiated

114 Administrative Issues in Data Use Steps to contact patients through a targeted approach for potential enrollment in research –Our office generates lists of potentially eligible patients –Lists forwarded to primary care provider (PCP) Discretion if provider needs to contact patient –PCP returns lists of authorized patients to our office –Investigator receives list of authorized patients –Investigator contacts patients in the context of the PCP

115 Research Data Use vs Patient Contact Additional authorization from primary care provider required before contacting patients –Labor intensive process –Can we delegate responsibility for obtaining authorization to investigator? –Does patient have to be contacted by provider and affirm interest in study participation prior to being contacted by investigators?

116 Questions for discussion Should we allow patients to opt out of allowing their data to be used in research, even without personal identifiers? Do we allow patients to refuse directed contact regarding research participation? If so, for how long? Federal law vs. “6:00 news” law

117 Resources HIPAA Administrative Simplification: –http://aspe.hhs.gov/admnsimp/ HIPAA Privacy: –http://www.hhs.gov/ocr/hipaa/ Workgroup on Electronic Data Interchange Strategic National Implementation Process: – American Association of Medical Colleges –


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