Confidentiality, Privacy and Security

1
Confidentiality, Privacy and Security
http//www.cs.princeton.edu/courses/archive/spr02/
cs495/Confidentiality20Privacy20and20Security.p
pt

• 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
• MDs
• Patients medical needs
• Documentation
• Interface with other providers
• Billing

8
Users

• Health insurance company
• Claims processing
• Approve consultation requests
• Laboratory
• Process specimens
• Results reporting
• Billing

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Users

• Pharmacy
• Fill prescription
• Billing
• Hospital
• Care provision
• Record of services
• Billing
• Vital statistics
• Regulatory agencies

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Users

• State bureau
• Birth statistics
• Epidemiology
• Accrediting organization
• Hospital review
• Employer
• Request claims data
• Review claims for reduction
• Benefits package adjustments

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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 MDs

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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

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Core security policies

• Confidentiality
• Email
• 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

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Approaches to identification

• Token based simple security
• House key, security card, transponder
• Knowledge based
• SSN, password, PIN
• Two-factor
• Card PIN

ID
Authentication
Card
PIN
Access

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Approaches to identification

• Authoritative ID

Access
T
ID
Authent- ication
Policy
F
Audit
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Identification

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

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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

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Biometric identifiers

• Should be universal attribute
• Consistent shouldnt change over time
• Unique
• Permanent
• Inimitable (voice can be separated from the
  individual)
• Collectible easy to gather the attribute
• Tamper resistant
• (Cheaply) comparable - template

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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

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Fingerprint
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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

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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

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Hand vein

• Infrared scanning of the architecture of the hand
  vessels

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Signature

• Architecture of the signature
• Dynamics of the signature (pressure and velocity)

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(No Transcript)
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Biometric identification issues

• Privacy, anonymity
• Legal issues not defined

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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 hasnt been messed with
• Nonrepudiation
• I didnt say that

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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
  shouldnt 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)

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Resources

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

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Initial access

• Site access
• System authorization
• Data authorization

Billing clerk
Site
System
Data
Worker
MD, RN
Computer vendor
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Technical capability

• Aspiring attacker (limited skills)
• Research target
• Masquerade as an employee
• Guess password
• Dumpster diving
• Become temporary employee

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Technical capability

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

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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

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Threat

• Threat 3
• Insiders who access information inappropriately
  for spite or profit
• London Times reported that anyones electronic
  record could be obtained for 300
• Threat 4
• Unauthorized physical intruder
• Fake labcoat

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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

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Countermeasures
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Counter threat 1

• Behavioral code
• Screen savers, automated logout
• ? Patient pseudonyms

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Counter threat 2

• Deterrence
• Sanctions
• Audit
• Encryption (user must obtain access keys)

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Counter threat 3

• Audit trails
• Sanctions appropriate to crime

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Counter threat 4

• Deterrence
• Strong technical measures (surveillance tapes)
• Strong identification and authentication measures

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Counter threat 5

• Obstacles
• Firewalls

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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
• VPNs
• 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 ones own system

67
Recommendations

• Develop security and confidentiality policies
• Publish
• Committees
• ISOs
• 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

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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

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Implications of the Health Insurance Portability
and Accountability Act of 1996
http//www.cs.princeton.edu/courses/archive/spr02/
cs495/HIPAA-princeton.ppt

• Mark Weiner, M.D.
• Assistant Professor of Medicine
• University of Pennsylvania
• mweiner_at_mail.med.upenn.edu
• Computer Science 495Special Topics in CS
  Medical Informatics
• February 21, 2002

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(No Transcript)
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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
Email addresses Social Security Numbers Medical
Record Numbers Health Plan Numbers License numbers
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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
• dont 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) Drivers Privacy Protection Act
(1994) Telecommunications Act (1996) Childrens
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

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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

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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

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Concern About Loss of Privacy

• Internet usage (1999 survey)
• 82 have used a computer
• 64 have used the internet
• 58 have sent e-mail
• 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

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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

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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?

• 1999- 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

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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

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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

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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

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HIPAA Timeline

• 1996 - 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)
• 1999 - DHHS becomes responsible for developing
  privacy regulations

89
HIPAA Timeline

• 1999 - DHHS proposes privacy standards and opens
  them up for public comment
• 1999-2000 DHHS receives 50,000 comments on
  regulations
• December 2000 - DHHS publishes Final Privacy
  Rule
• February 2001 - Enactment of Final Rule delayed
  because of administrative difficulties.
  Further public comment requested

90
HIPAA Timeline

• April 2001 - Privacy Rule implementation phase
  begins
• April 2003 - Deadline for covered entities to
  complete implementation plan

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HIPAA Stipulations for Using and Releasing
Information

• Notification
• Consent
• Authorization

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HIPAA Stipulations for Using and Releasing
Information

• Notification
• Informing patients in simple language regarding
  the manner in which their data is handled

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HIPAA Stipulations for Using and Releasing
Information

• Consent
• one time, general agreement to use the patients
  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 patients consent to use
  information for payment purposes.

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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

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Health-related activities covered by HIPAA

• Health Care
• Billing
• Marketing
• Fund Raising
• Research

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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

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HIPAA In Health Care

• Fax machines
• Hospital information networks
• E-mail
• Physical security of computer hardware

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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

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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

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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

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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.

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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
Penns High LevelApproach 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)

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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
107
Penns 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
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Data Integration and Access
HTML
FTP
IDX
Application Server (Apache)
Web Clients
Oracle SqlNet8
Data Warehouse (Oracle 8.1.5 on DEC Alpha DS20)
SMS
MSAccess
ODBC
Cerner
Dept system
Oracle Tools
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Available Data

• Ambulatory Data
• Primary and subspecialty care data-- Jan 1997 -
  May 2001
• Patient information
• Location
• Gender
• Race
• Birthdate
• Insurance carrier

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Available Data

• Inpatient data
• Patient information
• Admission Detail - 1988-1999 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
Penns Approach to Research Data Use

• Minimal oversight
• Information regarding a providers 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. 600 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
• http//snip.wedi.org/
• American Association of Medical Colleges
• http//aamc.org/members/gir/gasp