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Health Information Privacy & Security
SlideShare.net/Nawanan
Nawanan Theera-Ampornpunt
21 October 2020
Overview of IT Security
& Privacy
Malware
Threats to Information Security
Security Attacks
(Top) http://deadline.com/2014/12/sony-hack-timeline-any-pascal-the-interview-north-korea-1201325501/
(Bottom) http://www.bloomberg.com/news/articles/2014-12-07/sony-s-darkseoul-breach-stretched-from-thai-hotel-
to-hollywood
Privacy Threats in Thailand
https://www.posttoday.com/it/548240
Privacy Threats in Thai Health Care
https://www.blognone.com/node/79473
Why Software Testing is Important
Recycled Papers & Privacy
National Healthcare’s Worst Nightmare
https://www.straitstimes.com/singapore/personal-info-of-15m-singhealth-
patients-including-pm-lee-stolen-in-singapores-most
Ransomware Attack in Thai Hospitals
https://www.facebook.com/SaraburiHospital/photos/a.255929423747
8100/4366815263392646/
Sources of the Threats
▪ Hackers
▪ Viruses & Malware
▪ Poorly-designed systems
▪ Insiders (Employees)
▪ People’s ignorance & lack of knowledge
▪ Disasters & other incidents affecting information
systems
▪ Information risks
▪ Unauthorized access & disclosure of confidential information
▪ Unauthorized addition, deletion, or modification of information
▪ Operational risks
▪ System not functional (Denial of Service - DoS)
▪ System wrongly operated
▪ Personal risks
▪ Identity thefts
▪ Financial losses
▪ Disclosure of information that may affect employment or other
personal aspects (e.g. health information)
▪ Physical/psychological harms
▪ Organizational risks
▪ Financial losses
▪ Damage to reputation & trust
▪ Etc.
Consequences of Security Attacks
▪ Privacy: “The ability of an individual or group to
seclude themselves or information about
themselves and thereby reveal themselves
selectively.” (Wikipedia)
▪ Security: “The degree of protection to safeguard
... person against danger, damage, loss, and
crime.” (Wikipedia)
▪ Information Security: “Protecting information
and information systems from unauthorized
access, use, disclosure, disruption,
modification, perusal, inspection, recording or
destruction” (Wikipedia)
Privacy & Security
Information Security
▪ Confidentiality
▪ Integrity
▪ Availability
Examples of Confidentiality Risks
http://usatoday30.usatoday.com/life/people/2007-10-10-clooney_N.htm
Examples of Integrity Risks
http://news.softpedia.com/news/700-000-InMotion-Websites-Hacked-by-TiGER-M-TE-223607.shtml
Web Defacements
Examples of Availability Risks
http://en.wikipedia.org/wiki/Blaster_worm
Viruses/worms that led to instability &
system restart (e.g. Blaster worm)
Examples of Availability Risks
http://en.wikipedia.org/wiki/Ariane_5_Flight_501
Ariane 5 Flight 501 Rocket Launch Failure
Cause: Software bug on rocket acceleration due to data conversion
from a 64-bit floating point number to a 16-bit signed integer without
proper checks, leading to arithmatic overflow
Interesting Resources
▪ http://en.wikipedia.org/wiki/List_of_software_bugs
▪ http://en.wikipedia.org/wiki/Notable_computer_viruses_an
d_worms
▪ http://en.wikipedia.org/wiki/Hacktivism
▪ http://en.wikipedia.org/wiki/Website_defacement
▪ http://en.wikipedia.org/wiki/Hacker_(computer_security)
▪ http://en.wikipedia.org/wiki/List_of_hackers
Protecting Information
Privacy & Security
http://www.aclu.org/ordering-pizza
Privacy Protections: Why?
Security & Privacy
http://en.wikipedia.org/wiki/A._S._Bradford_House
Privacy Case Studies
http://pantip.com/topic/35330409/
Measures to Protect Privacy
• Informed consent
• Privacy culture
• User awareness building & education
• Organizational policy & regulations
▪ Enforcement
▪ Ongoing privacy & security
assessments, monitoring, and protection
▪ Attack
▪ An attempt to breach system security
▪ Threat
▪ A scenario that can harm a system
▪ Vulnerability
▪ The “hole” that is used in the attack
Common Security Terms
▪ Identify some possible means an
attacker could use to conduct a
security attack
Class Exercise
Alice
Simplified Attack Scenarios
Server Bob
Eve/Mallory
Alice
Simplified Attack Scenarios
Server Bob
- Physical access to client computer
- Electronic access (password)
- Tricking user into doing something
(malware, phishing & social
engineering)
Eve/Mallory
Alice
Simplified Attack Scenarios
Server Bob
- Intercepting (eavesdropping or
“sniffing”) data in transit
- Modifying data (“Man-in-the-middle”
attacks)
- “Replay” attacks
Eve/Mallory
Alice
Simplified Attack Scenarios
Server Bob
- Unauthorized access to servers through
- Physical means
- User accounts & privileges
- Attacks through software vulnerabilities
- Attacks using protocol weaknesses
- DoS / DDoS attacks
Eve/Mallory
Alice
Simplified Attack Scenarios
Server Bob
Other & newer forms of
attacks possible Eve/Mallory
Alice
Safeguarding Against Attacks
Server Bob
Administrative Security
- Security & privacy policy
- Governance of security risk management & response
- Uniform enforcement of policy & monitoring
- Disaster recovery planning (DRP) & Business continuity
planning/management (BCP/BCM)
- Legal obligations, requirements & disclaimers
Alice
Safeguarding Against Attacks
Server Bob
Physical Security
- Protecting physical access of clients & servers
- Locks & chains, locked rooms, security cameras
- Mobile device security
- Secure storage & secure disposition of storage devices
Alice
Safeguarding Against Attacks
Server Bob
User Security
- User account management
- Strong p/w policy (length, complexity, expiry, no meaning)
- Principle of Least Privilege
- “Clear desk, clear screen policy”
- Audit trails
- Education, awareness building & policy enforcement
- Alerts & education about phishing & social engineering
Alice
Safeguarding Against Attacks
Server Bob
System Security
- Antivirus, antispyware, personal firewall, intrusion
detection/prevention system (IDS/IPS), log files, monitoring
- Updates, patches, fixes of operating system vulnerabilities &
application vulnerabilities
- Redundancy (avoid “Single Point of Failure”)
- Honeypots
Alice
Safeguarding Against Attacks
Server Bob
Software Security
- Software (clients & servers) that is secure by design
- Software testing against failures, bugs, invalid inputs,
performance issues & attacks
- Updates to patch vulnerabilities
Alice
Safeguarding Against Attacks
Server Bob
Network Security
- Access control (physical & electronic) to network devices
- Use of secure network protocols if possible
- Data encryption during transit if possible
- Bandwidth monitoring & control
Alice
Safeguarding Against Attacks
Server Bob
Database Security
- Access control to databases & storage devices
- Encryption of data stored in databases if necessary
- Secure destruction of data after use
- Access control to queries/reports
- Security features of database management systems (DBMS)
- Data backups (online vs. offline)
User Security
▪ Access control
▪ Selective restriction of access to the system
▪ Role-based access control
▪ Access control based on the person’s role
(rather than identity)
▪ Audit trails
▪ Logs/records that provide evidence of
sequence of activities
User Security
▪ Identification
▪ Identifying who you are
▪ Usually done by user IDs or some other unique codes
▪ Authentication
▪ Confirming that you truly are who you identify
▪ Usually done by keys, PIN, passwords or biometrics
▪ Authorization
▪ Specifying/verifying how much you have access
▪ Determined based on system owner’s policy & system
configurations
▪ “Principle of Least Privilege”
User Security
▪ Nonrepudiation
▪ Proving integrity, origin, & performer of an
activity without the person’s ability to refute
his actions
▪ Most common form: signatures
▪ Electronic signatures offer varying degrees of
nonrepudiation
▪ PIN/password vs. biometrics
▪ Digital certificates (in public key infrastructure
- PKI) often used to ascertain nonrepudiation
User Security
▪ Multiple-Factor Authentication
▪ Two-Factor Authentication
▪ Use of multiple means (“factors”) for authentication
▪ Types of Authentication Factors
▪ Something you know
▪ Password, PIN, etc.
▪ Something you have
▪ Keys, cards, tokens, devices (e.g. mobile phones)
▪ Something you are
▪ Biometrics
User Security
Need for Strong Password Policy
So, two informaticians
walk into a bar...
The bouncer says,
"What's the password."
One says, "Password?"
The bouncer lets them
in.
Credits: @RossMartin & AMIA (2012)
Unknown Internet sources, via
http://pikabu.ru/story/interesno_kakoy_zhe_u_nikh_parol_4274737,
via Facebook page “สอนแฮกเว็บแบบแมวๆ”
What’s the Password?
Written Password
Recommended Password Policy
▪ Length
▪ 8 characters or more (to slow down brute-force attacks)
▪ Complexity (to slow down brute-force attacks)
▪ Consists of 3 of 4 categories of characters
▪ Uppercase letters
▪ Lowercase letters
▪ Numbers
▪ Symbols (except symbols that have special uses by the
system or that can be used to hack system, e.g. SQL
Injection)
▪ No meaning (“Dictionary Attacks”)
▪ Not simple patterns (12345678, 11111111) (to slow down brute-
force attacks & prevent dictionary attacks)
▪ Not easy to guess (birthday, family names, etc.) (to prevent
unknown & known persons from guessing)Personal opinion. No legal responsibility assumed.
Recommended Password Policy
▪ Expiration (to make brute-force attacks not possible)
▪ 6-8 months
▪ Decreasing over time because of increasing computer’s
speed
▪ But be careful! Too short duration will force users to write
passwords down
▪ Secure password storage in database or system
(encrypted or store only password hashes)
▪ Secure password confirmation
▪ Secure “forget password” policy
▪ Different password for each account. Create variations
to help remember. If not possible, have different sets of
accounts for differing security needs (e.g., bank
accounts vs. social media sites) Personal opinion. No legal responsibility assumed.
Clear Desk, Clear Screen Policy
http://pixabay.com/en/post-it-sticky-note-note-corner-148282/
Techniques to Remember Passwords
▪ http://www.wikihow.com/Create-a-Password-You-Can-
Remember
▪ Note that some of the techniques are less secure!
▪ One easy & secure way: password mnemonic
▪ Think of a full sentence that you can remember
▪ Ideally the sentence should have 8 or more words, with
numbers and symbols
▪ Use first character of each word as password
▪ Sentence: I love reading all 7 Harry Potter books!
▪ Password: Ilra7HPb!
▪ Voila!
Personal opinion. No legal responsibility assumed.
Dictionary Attack:
A story from
a computer security
course
Keylogger Attack:
A story from
a medical student’s life
Dear mail.mahidol.ac.th Email Account User,
We wrote to you on 11th January 2010 advising that you change the password on
your account in order to prevent any unauthorised account access following
the network instruction we previously communicated.
all Mailhub systems will undergo regularly scheduled maintenance. Access
to your e-mail via the Webmail client will be unavailable for some time
during this maintenance period. We are currently upgrading our data base
and e-mail account center i.e homepage view. We shall be deleting old
[https://mail.mahidol.ac.th/l accounts which are no longer active to create
more space for new accountsusers. we have also investigated a system wide
security audit to improve and enhance
our current security.
In order to continue using our services you are require to update and
re-comfirmed your email account details as requested below. To complete
your account re-comfirmation,you must reply to this email immediately and
enter your account
details as requested below.
Username :
Password :
Date of Birth:
Future Password :
Social Engineering Examples
Real social-engineering e-mail received by Speaker
Phishing
Real phishing e-mail received by Speaker
Checking for Encryption for Website Connections
Microsoft Edge
Google Chrome
Checking for Encryption for Website Connections
Mozilla Firefox
Google Chrome
1
Checking for Encryption for Website Connections
Mozilla Firefox
Google Chrome
2
1
Checking for Encryption for Website Connections
Mozilla Firefox
Google Chrome
2
1
3
Checking for Encryption for Website Connections
1
Mozilla Firefox
Google Chrome
2
3
4
Checking for Encryption for Website Connections
1
Mozilla Firefox
Google Chrome
2
3
4
Checking for Encryption for Website Connections
▪ Poor grammar
▪ Lots of typos
▪ Trying very hard to convince you to open
attachment, click on link, or reply without
enough detail
▪ May appear to be from known person (rely on
trust & innocence)
Signs of a Phishing Attack
▪ Don’t be too trusting of people
▪ Always be suspicious & alert
▪ An e-mail with your friend’s name & info doesn’t have to
come from him/her
▪ Look for signs of phishing attacks
▪ Don’t open attachments unless you expect them
▪ Scan for viruses before opening attachments
▪ Don’t click links in e-mail. Directly type in browser using
known & trusted URLs
▪ Especially cautioned if ask for passwords, bank
accounts, credit card numbers, social security numbers,
etc.
Ways to Protect against Phishing
Malware
▪ Malicious software - Any code with intentional,
undesirable side effects
▪ Virus
▪ Worm
▪ Trojan
▪ Spyware
▪ Logic Bomb/Time Bomb
▪ Backdoor/Trapdoor
▪ Rootkit
▪ Botnet
Malware
▪ Virus
▪ Propagating malware that requires user action
to propagate
▪ Infects executable files, data files with
executable contents (e.g. Macro), boot
sectors
▪ Worm
▪ Self-propagating malware
▪ Trojan
▪ A legitimate program with additional, hidden
functionality
Malware
▪ Spyware
▪ Trojan that spies for & steals personal
information
▪ Logic Bomb/Time Bomb
▪ Malware that triggers under certain conditions
▪ Backdoor/Trapdoor
▪ A hole left behind by malware for future
access
Malware
▪ Rogue Antispyware
▪ Software that tricks or forces users to pay before
fixing (real or hoax) spyware detected
▪ Rootkit
▪ A stealth program designed to hide existence of
certain processes or programs from detection
▪ Botnet
▪ A collection of Internet-connected computers that
have been compromised (bots) which controller of the
botnet can use to do something (e.g. do DDoS
attacks)
Malware
▪ Installed & updated antivirus, antispyware, &
personal firewall
▪ Check for known signatures
▪ Check for improper file changes (integrity failures)
▪ Check for generic patterns of malware (for unknown
malware): “Heuristics scan”
▪ Firewall: Block certain network traffic in and out
▪ Sandboxing
▪ Network monitoring & containment
▪ User education
▪ Software patches, more secure protocols
Defense Against Malware
▪ Social media spams/scams/clickjacking
▪ Social media privacy issues
▪ User privacy settings
▪ Location services
▪ Mobile device malware & other privacy risks
▪ Stuxnet (advanced malware targeting certain
countries)
▪ Advanced persistent threats (APT) by
governments & corporations against specific
targets
Newer Threats
Ransomware ระบาดใน Healthcare
Top: http://www.healthcareitnews.com/news/more-half-hospitals-hit-ransomware-last-12-months
Bottom: http://www.mirror.co.uk/news/uk-news/ransomware-nhs-cyber-attack-live-10409420
Infected with WannaCry
https://cdn.securelist.com/files/2017/05/wannacry_05.png
WannaCry: Infection Flow
http://blog.trendmicro.com/trendlabs-security-intelligence/files/2017/05/WannaCry-infection-flow02.jpg
Medical Device Security
Malware &
Medical Devices
Preventing from Ransomware
https://us-cert.cisa.gov/sites/default/files/publications/Ransomware_Executive_One-
Pager_and_Technical_Document-FINAL.pdf
▪ Most common reason for security bugs is
invalid programming assumptions that attackers
will look for
▪ Weak input checking
▪ Buffer overflow
▪ Integer overflow
▪ Race condition (Time of Check / Time of Use
vulnerabilities)
▪ Running programs in new environments
Software Security
Adapted from Nicholas Hopper’s teaching slides for UMN Computer Security Class Fall 2006 CSCI 5271
▪ Defense in Depth
▪ Multiple layers of security defense are
placed throughout a system to provide
redundancy in the event a security
control fails
▪ Secure the weakest link
▪ Promote privacy
▪ Trust no one
Secure Software Design Principles
Saltzer & Schroeder (1975), Viega & McGraw (2000)
Adapted from Nicholas Hopper’s teaching slides for UMN Computer Security Class Fall 2006 CSCI 5271
http://en.wikipedia.org/wiki/Defense_in_depth_(computing)
▪ Modular design
▪ Check error conditions on return values
▪ Validate inputs (whitelist vs. blacklist)
▪ Avoid infinite loops, memory leaks
▪ Check for integer overflows
▪ Language/library choices
▪ Development processes
Secure Software Best Practices
Adapted from Nicholas Hopper’s teaching slides for UMN Computer Security Class Fall 2006 CSCI 5271
▪ Consider a log-in form on a web page
Example of Weak Input Checking:
SQL Injection
▪ Source code would look
something like this:
statement = "SELECT * FROM users
WHERE name = '" + userName + "';"
▪ Attacker would enter as username:
' or '1'='1
▪ Which leads to this always-true query:
▪ statement = "SELECT * FROM users
WHERE name = '" + "' or '1'='1" + "';"
statement = "SELECT * FROM users WHERE name = '' or '1'='1';"
http://en.wikipedia.org/wiki/SQL_injection
U.S. National Institute of Standards and Technology (NIST)
Cybersecurity Framework
Technology
ProcessPeople
Balanced IT Security Management
How to Deal with Security
Privacy Laws
▪ Respect for Persons (Autonomy)
▪ Beneficence
▪ Non-maleficence
▪ Justice
Ethical Principles in Bioethics
Hippocratic Oath
...
What I may see or hear in the course of
treatment or even outside of the
treatment in regard to the life of men,
which on no account one must spread
abroad, I will keep myself holding such
things shameful to be spoken about.
...
http://en.wikipedia.org/wiki/Hippocratic_Oath
HIPAA
▪ Health Insurance Portability and Accountability Act of 1996
http://www.gpo.gov/fdsys/pkg/PLAW-104publ191/pdf/PLAW-
104publ191.pdf
▪ More stringent state privacy laws apply
▪ HIPAA Goals
▪ To protect health insurance coverage for workers & families
when they change or lose jobs (Title I)
▪ To require establishment of national standards for electronic
health care transactions and national identifiers for providers,
health insurance plans, and employers (Title II: “Administrative
Simplification” provisions)
▪ Administrative Simplification provisions also address security &
privacy of health data
U.S. Health Information Privacy Law
http://en.wikipedia.org/wiki/Health_Insurance_Portability_and_Accountability_Act
▪ Title I: Health Care Access, Portability, and
Renewability
▪ Title II: Preventing Health Care Fraud and
Abuse; Administrative Simplification; Medical
Liability Reform
▪ Requires Department of Health & Human
Services (HHS) to draft rules aimed at
increasing efficiency of health care system by
creating standards for use and dissemination of
health care information
HIPAA (U.S.)
▪ Title III: Tax-Related Health Provisions
▪ Title IV: Application and Enforcement of
Group Health Plan Requirements
▪ Title V: Revenue Offsets
HIPAA (U.S.)
▪ HHS promulgated 5 Administrative
Simplification rules
▪ Privacy Rule
▪ Transactions and Code Sets Rule
▪ Security Rule
▪ Unique Identifiers Rule
▪ Enforcement Rule
HIPAA (U.S.)
▪ Covered Entities
▪ A health plan
▪ A health care clearinghouse
▪ A healthcare provider who transmits any health
information in electronic form in connection with a
transaction to enable health information to be exchanged
electronically
▪ Business Associates
Some HIPAA Definitions
▪ Protected Health Information (PHI)
▪ Individually identifiable health information transmitted or maintained
in electronic media or other form or medium
▪ Individually Identifiable Health Information
▪ Any information, including demographic information collected from
an individual, that—
▪ (A) is created or received by a CE; and
▪ (B) relates to the past, present, or future physical
▪ or mental health or condition of an individual, the provision of health
care to an individual, or the past, present, or future payment for the
provision of health care to an individual, and—
▪ (i) identifies the individual; or
▪ (ii) with respect to which there is a reasonable basis to believe that
the information can be used to identify the individual.
Some HIPAA Definitions
▪ Name
▪ Address
▪ Phone number
▪ Fax number
▪ E-mail address
▪ SSN
▪ Birthdate
▪ Medical Record No.
▪ Health Plan ID
▪ Treatment date
▪ Account No.
▪ Certificate/License No.
▪ Device ID No.
▪ Vehicle ID No.
▪ Drivers license No.
▪ URL
▪ IP Address
▪ Biometric identifier
including fingerprints
▪ Full face photo
Protected Health Information –
Personal Identifiers in PHI
▪ Establishes national standards to protect PHI; applies to CE &
business associates
▪ Requires appropriate safeguards to protect privacy of PHI
▪ Sets limits & conditions on uses & disclosures that may be made
without patient authorization
▪ Gives patients rights over their health information, including
rights to examine & obtain copy of health records & to request
corrections
HIPAA Privacy Rule
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
▪ Timeline
▪ November 3, 1999 Proposed Privacy Rule
▪ December 28, 2000 Final Privacy Rule
▪ August 14, 2002 Modifications to Privacy Rule
▪ April 14, 2003 Compliance Date for most CE
▪ Full text (as amended)
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/
adminsimpregtext.pdf
HIPAA Privacy Rule
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
▪ Some permitted uses and disclosures
▪ Use of PHI
▪ Sharing, application, use, examination or
analysis within the entity that maintains the
PHI
▪ Disclosure of PHI
▪ Release or divulgence of information by an
entity to persons or organizations outside of
that entity.
HIPAA Privacy Rule
▪ A covered entity may not use or disclose
PHI, except
▪ with individual consent for treatment,
payment or healthcare operations (TPO)
▪ with individual authorization for other
purposes
▪ without consent or authorization for
governmental and other specified
purposes
HIPAA Privacy Rule
▪ Treatment, payment, health care operations
(TPO)
▪ Quality improvement
▪ Competency assurance
▪ Medical reviews & audits
▪ Insurance functions
▪ Business planning & administration
▪ General administrative activities
HIPAA Privacy Rule
▪ Uses & disclosures without the need for patient
authorization permitted in some circumstances
▪ Required by law
▪ For public health activities
▪ About victims of abuse, neglect, or domestic
violence
▪ For health oversight activities
▪ For judicial & administrative proceedings
▪ For law enforcement purposes
▪ About decedents
HIPAA Privacy Rule
▪ Uses & disclosures without the need for patient
authorization permitted in some circumstances
▪ For cadaveric organ, eye, or tissue donation purposes
▪ For research purposes
▪ To avert a serious threat to health or safety
▪ For workers’ compensation
▪ For specialized government functions
▪ Military & veterans activities
▪ National security & intelligence activities
▪ Protective services for President & others
▪ Medical suitability determinants
▪ Correctional institutions
▪ CE that are government programs providing public benefits
HIPAA Privacy Rule
▪ Control use and disclosure of PHI
▪ Notify patients of information practices (NPP, Notice of Privacy
Practices)
▪ Specifies how CE can use and share PHI
▪ Specifies patient’s rights regarding their PHI
▪ Provide means for patients to access their own record
▪ Obtain authorization for non-TPO uses and disclosures
▪ Log disclosures
▪ Restrict use or disclosures
▪ Minimum necessary
▪ Privacy policy and practices
▪ Business Associate agreements
▪ Other applicable statutes
▪ Provide management oversight and response to minimize threats and
breaches of privacy
Responsibilities of a CE
From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
▪ Individually identifiable health information collected
and used solely for research IS NOT PHI
▪ Researchers obtaining PHI from a CE must obtain
the subject’s authorization or must justify an
exception:
▪ Waiver of authorization (obtain from the IRB)
▪ Limited Data Set (with data use agreement)
▪ De-identified Data Set
▪ HIPAA Privacy supplements the Common Rule
and the FDA’s existing protection for human
subjects
HIPAA & Research
From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
▪ De-identified Data Set
▪ Remove all 18 personal identifiers of subjects,
relatives, employers, or household members
▪ OR biostatistician confirms that individual cannot be
identified with the available information
▪ Limited Data Set
▪ May include Zip, Birthdate, Date of death, date of
service, geographic subdivision
▪ Remove all other personal identifiers of subject, etc.
▪ Data Use Agreement signed by data recipient that
there will be no attempt to re-identify the subject
Research Data Sets
From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
▪ Assure the CE that all research-initiated HIPAA
requirements have been met
▪ Provide letter of approval to the researcher to
conduct research using PHI
▪ OR, Certify and document that waiver of
authorization criteria have been met
▪ Review and approve all authorizations and data
use agreements
▪ Retain records documenting HIPAA actions for 6
years
IRB’s New Responsibility
From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
▪ Establishes national standards to protect
individuals’ electronic PHI that is created,
received, used, or maintained by a CE.
▪ Requires appropriate safeguards to ensure
confidentiality, integrity & security of
electronic PHI
▪ Administrative safeguards
▪ Physical safeguards
▪ Technical safeguards
HIPAA Security Rule
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
▪ Timeline
▪ August 12, 1998 Proposed Security Rule
▪ February 20, 2003 Final Security Rule
▪ April 21, 2005 Compliance Date for most CE
▪ Full Text
http://www.hhs.gov/ocr/privacy/hipaa/
administrative/securityrule/securityrulepdf.pdf
HIPAA Security Rule
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/index.html
▪ The HIPAA Security Rule is:
▪ A set of information security “best practices”
▪ A minimum baseline for security
▪ An outline of what to do, and what procedures
should be in place
▪ The HIPAA Security Rule is not:
▪ A set of specific instructions
▪ A set of rules for universal, unconditional
implementation
▪ A document outlining specific implementations
(vendors, equipment, software, etc.)
HIPAA Security Rule: Meaning
From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
▪ The HIPAA Security Rule is designed to be:
▪ Technology-neutral
▪ Scalable (doesn’t require all CEs to apply the same
policies)
▪ Flexible (allows CEs to determine their own needs)
▪ Comprehensive (covers technical, business, and
behavioral issues)
HIPAA Security Rule: Meaning
From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
▪ Many rules are either Required or Addressable
▪ Required:
▪ Compliance is mandatory
▪ Addressable:
▪ If a specification in the Rule is reasonable and
appropriate for the CE, then the CE must implement
▪ Otherwise, documentation must be made of the
reasons the policy cannot/will not be implemented,
and when necessary, offer an alternative
HIPAA Security Rule: Meaning
From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
▪ Breach notification
▪ Extension of complete Privacy & Security
HIPAA provisions to business associates of
covered entities
▪ New rules for accounting of disclosures of a
patient’s health information
New in HITECH Act of 2009
▪ Conflicts between federal vs. state laws
▪ Variations among state laws of different
states
▪ HIPAA only covers “covered entities”
▪ No general privacy laws in place, only a few
sectoral privacy laws e.g. HIPAA
Health Information Privacy Law:
U.S. Challenges
▪ Canada - The Privacy Act (1983), Personal
Information Protection and Electronic Data
Act of 2000
▪ EU Countries - EU General Data Protection
Regulation (GDPR)
▪ Australia - Privacy Act of 1988
Health Information Privacy Law:
Other Western Countries
▪ General Data Privacy Law
▪ There exists general law protecting privacy
of all types of information (financial,
educational, health, etc.)
▪ Sectoral Data Privacy Law
▪ Each sector (e.g. health sector) has its
own information privacy laws without a
general law
Two Systems of Privacy Laws
Pros & Cons
General Data
Privacy Law
▪ Pros: Covers all types
of information with
uniform standard of
protection
▪ Cons: May not be
flexible for specific
requirements in each
industry or for each
type of information
(e.g. health)
Sectoral Data
Privacy Law
▪ Pros: Protections
specific to each type
of information (e.g.
health information) or
nature of each
industry
▪ Cons: Not covering
other types of
information or those
kept by other
organizations outside
the sector, and no
uniform standard of
protections
How to Deal with Security

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Health Privacy & Security Overview

  • 1. Health Information Privacy & Security SlideShare.net/Nawanan Nawanan Theera-Ampornpunt 21 October 2020
  • 2. Overview of IT Security & Privacy
  • 4. Security Attacks (Top) http://deadline.com/2014/12/sony-hack-timeline-any-pascal-the-interview-north-korea-1201325501/ (Bottom) http://www.bloomberg.com/news/articles/2014-12-07/sony-s-darkseoul-breach-stretched-from-thai-hotel- to-hollywood
  • 5. Privacy Threats in Thailand https://www.posttoday.com/it/548240
  • 6. Privacy Threats in Thai Health Care https://www.blognone.com/node/79473
  • 7. Why Software Testing is Important
  • 9. National Healthcare’s Worst Nightmare https://www.straitstimes.com/singapore/personal-info-of-15m-singhealth- patients-including-pm-lee-stolen-in-singapores-most
  • 10. Ransomware Attack in Thai Hospitals https://www.facebook.com/SaraburiHospital/photos/a.255929423747 8100/4366815263392646/
  • 11. Sources of the Threats ▪ Hackers ▪ Viruses & Malware ▪ Poorly-designed systems ▪ Insiders (Employees) ▪ People’s ignorance & lack of knowledge ▪ Disasters & other incidents affecting information systems
  • 12. ▪ Information risks ▪ Unauthorized access & disclosure of confidential information ▪ Unauthorized addition, deletion, or modification of information ▪ Operational risks ▪ System not functional (Denial of Service - DoS) ▪ System wrongly operated ▪ Personal risks ▪ Identity thefts ▪ Financial losses ▪ Disclosure of information that may affect employment or other personal aspects (e.g. health information) ▪ Physical/psychological harms ▪ Organizational risks ▪ Financial losses ▪ Damage to reputation & trust ▪ Etc. Consequences of Security Attacks
  • 13. ▪ Privacy: “The ability of an individual or group to seclude themselves or information about themselves and thereby reveal themselves selectively.” (Wikipedia) ▪ Security: “The degree of protection to safeguard ... person against danger, damage, loss, and crime.” (Wikipedia) ▪ Information Security: “Protecting information and information systems from unauthorized access, use, disclosure, disruption, modification, perusal, inspection, recording or destruction” (Wikipedia) Privacy & Security
  • 14. Information Security ▪ Confidentiality ▪ Integrity ▪ Availability
  • 15. Examples of Confidentiality Risks http://usatoday30.usatoday.com/life/people/2007-10-10-clooney_N.htm
  • 16. Examples of Integrity Risks http://news.softpedia.com/news/700-000-InMotion-Websites-Hacked-by-TiGER-M-TE-223607.shtml Web Defacements
  • 17. Examples of Availability Risks http://en.wikipedia.org/wiki/Blaster_worm Viruses/worms that led to instability & system restart (e.g. Blaster worm)
  • 18. Examples of Availability Risks http://en.wikipedia.org/wiki/Ariane_5_Flight_501 Ariane 5 Flight 501 Rocket Launch Failure Cause: Software bug on rocket acceleration due to data conversion from a 64-bit floating point number to a 16-bit signed integer without proper checks, leading to arithmatic overflow
  • 19. Interesting Resources ▪ http://en.wikipedia.org/wiki/List_of_software_bugs ▪ http://en.wikipedia.org/wiki/Notable_computer_viruses_an d_worms ▪ http://en.wikipedia.org/wiki/Hacktivism ▪ http://en.wikipedia.org/wiki/Website_defacement ▪ http://en.wikipedia.org/wiki/Hacker_(computer_security) ▪ http://en.wikipedia.org/wiki/List_of_hackers
  • 24. Measures to Protect Privacy • Informed consent • Privacy culture • User awareness building & education • Organizational policy & regulations ▪ Enforcement ▪ Ongoing privacy & security assessments, monitoring, and protection
  • 25. ▪ Attack ▪ An attempt to breach system security ▪ Threat ▪ A scenario that can harm a system ▪ Vulnerability ▪ The “hole” that is used in the attack Common Security Terms
  • 26. ▪ Identify some possible means an attacker could use to conduct a security attack Class Exercise
  • 28. Alice Simplified Attack Scenarios Server Bob - Physical access to client computer - Electronic access (password) - Tricking user into doing something (malware, phishing & social engineering) Eve/Mallory
  • 29. Alice Simplified Attack Scenarios Server Bob - Intercepting (eavesdropping or “sniffing”) data in transit - Modifying data (“Man-in-the-middle” attacks) - “Replay” attacks Eve/Mallory
  • 30. Alice Simplified Attack Scenarios Server Bob - Unauthorized access to servers through - Physical means - User accounts & privileges - Attacks through software vulnerabilities - Attacks using protocol weaknesses - DoS / DDoS attacks Eve/Mallory
  • 31. Alice Simplified Attack Scenarios Server Bob Other & newer forms of attacks possible Eve/Mallory
  • 32. Alice Safeguarding Against Attacks Server Bob Administrative Security - Security & privacy policy - Governance of security risk management & response - Uniform enforcement of policy & monitoring - Disaster recovery planning (DRP) & Business continuity planning/management (BCP/BCM) - Legal obligations, requirements & disclaimers
  • 33. Alice Safeguarding Against Attacks Server Bob Physical Security - Protecting physical access of clients & servers - Locks & chains, locked rooms, security cameras - Mobile device security - Secure storage & secure disposition of storage devices
  • 34. Alice Safeguarding Against Attacks Server Bob User Security - User account management - Strong p/w policy (length, complexity, expiry, no meaning) - Principle of Least Privilege - “Clear desk, clear screen policy” - Audit trails - Education, awareness building & policy enforcement - Alerts & education about phishing & social engineering
  • 35. Alice Safeguarding Against Attacks Server Bob System Security - Antivirus, antispyware, personal firewall, intrusion detection/prevention system (IDS/IPS), log files, monitoring - Updates, patches, fixes of operating system vulnerabilities & application vulnerabilities - Redundancy (avoid “Single Point of Failure”) - Honeypots
  • 36. Alice Safeguarding Against Attacks Server Bob Software Security - Software (clients & servers) that is secure by design - Software testing against failures, bugs, invalid inputs, performance issues & attacks - Updates to patch vulnerabilities
  • 37. Alice Safeguarding Against Attacks Server Bob Network Security - Access control (physical & electronic) to network devices - Use of secure network protocols if possible - Data encryption during transit if possible - Bandwidth monitoring & control
  • 38. Alice Safeguarding Against Attacks Server Bob Database Security - Access control to databases & storage devices - Encryption of data stored in databases if necessary - Secure destruction of data after use - Access control to queries/reports - Security features of database management systems (DBMS) - Data backups (online vs. offline)
  • 40. ▪ Access control ▪ Selective restriction of access to the system ▪ Role-based access control ▪ Access control based on the person’s role (rather than identity) ▪ Audit trails ▪ Logs/records that provide evidence of sequence of activities User Security
  • 41. ▪ Identification ▪ Identifying who you are ▪ Usually done by user IDs or some other unique codes ▪ Authentication ▪ Confirming that you truly are who you identify ▪ Usually done by keys, PIN, passwords or biometrics ▪ Authorization ▪ Specifying/verifying how much you have access ▪ Determined based on system owner’s policy & system configurations ▪ “Principle of Least Privilege” User Security
  • 42. ▪ Nonrepudiation ▪ Proving integrity, origin, & performer of an activity without the person’s ability to refute his actions ▪ Most common form: signatures ▪ Electronic signatures offer varying degrees of nonrepudiation ▪ PIN/password vs. biometrics ▪ Digital certificates (in public key infrastructure - PKI) often used to ascertain nonrepudiation User Security
  • 43. ▪ Multiple-Factor Authentication ▪ Two-Factor Authentication ▪ Use of multiple means (“factors”) for authentication ▪ Types of Authentication Factors ▪ Something you know ▪ Password, PIN, etc. ▪ Something you have ▪ Keys, cards, tokens, devices (e.g. mobile phones) ▪ Something you are ▪ Biometrics User Security
  • 44. Need for Strong Password Policy So, two informaticians walk into a bar... The bouncer says, "What's the password." One says, "Password?" The bouncer lets them in. Credits: @RossMartin & AMIA (2012)
  • 45. Unknown Internet sources, via http://pikabu.ru/story/interesno_kakoy_zhe_u_nikh_parol_4274737, via Facebook page “สอนแฮกเว็บแบบแมวๆ” What’s the Password?
  • 47. Recommended Password Policy ▪ Length ▪ 8 characters or more (to slow down brute-force attacks) ▪ Complexity (to slow down brute-force attacks) ▪ Consists of 3 of 4 categories of characters ▪ Uppercase letters ▪ Lowercase letters ▪ Numbers ▪ Symbols (except symbols that have special uses by the system or that can be used to hack system, e.g. SQL Injection) ▪ No meaning (“Dictionary Attacks”) ▪ Not simple patterns (12345678, 11111111) (to slow down brute- force attacks & prevent dictionary attacks) ▪ Not easy to guess (birthday, family names, etc.) (to prevent unknown & known persons from guessing)Personal opinion. No legal responsibility assumed.
  • 48. Recommended Password Policy ▪ Expiration (to make brute-force attacks not possible) ▪ 6-8 months ▪ Decreasing over time because of increasing computer’s speed ▪ But be careful! Too short duration will force users to write passwords down ▪ Secure password storage in database or system (encrypted or store only password hashes) ▪ Secure password confirmation ▪ Secure “forget password” policy ▪ Different password for each account. Create variations to help remember. If not possible, have different sets of accounts for differing security needs (e.g., bank accounts vs. social media sites) Personal opinion. No legal responsibility assumed.
  • 49. Clear Desk, Clear Screen Policy http://pixabay.com/en/post-it-sticky-note-note-corner-148282/
  • 50. Techniques to Remember Passwords ▪ http://www.wikihow.com/Create-a-Password-You-Can- Remember ▪ Note that some of the techniques are less secure! ▪ One easy & secure way: password mnemonic ▪ Think of a full sentence that you can remember ▪ Ideally the sentence should have 8 or more words, with numbers and symbols ▪ Use first character of each word as password ▪ Sentence: I love reading all 7 Harry Potter books! ▪ Password: Ilra7HPb! ▪ Voila! Personal opinion. No legal responsibility assumed.
  • 51. Dictionary Attack: A story from a computer security course
  • 52. Keylogger Attack: A story from a medical student’s life
  • 53. Dear mail.mahidol.ac.th Email Account User, We wrote to you on 11th January 2010 advising that you change the password on your account in order to prevent any unauthorised account access following the network instruction we previously communicated. all Mailhub systems will undergo regularly scheduled maintenance. Access to your e-mail via the Webmail client will be unavailable for some time during this maintenance period. We are currently upgrading our data base and e-mail account center i.e homepage view. We shall be deleting old [https://mail.mahidol.ac.th/l accounts which are no longer active to create more space for new accountsusers. we have also investigated a system wide security audit to improve and enhance our current security. In order to continue using our services you are require to update and re-comfirmed your email account details as requested below. To complete your account re-comfirmation,you must reply to this email immediately and enter your account details as requested below. Username : Password : Date of Birth: Future Password : Social Engineering Examples Real social-engineering e-mail received by Speaker
  • 54. Phishing Real phishing e-mail received by Speaker
  • 55. Checking for Encryption for Website Connections Microsoft Edge
  • 56. Google Chrome Checking for Encryption for Website Connections
  • 57. Mozilla Firefox Google Chrome 1 Checking for Encryption for Website Connections
  • 58. Mozilla Firefox Google Chrome 2 1 Checking for Encryption for Website Connections
  • 59. Mozilla Firefox Google Chrome 2 1 3 Checking for Encryption for Website Connections
  • 60. 1 Mozilla Firefox Google Chrome 2 3 4 Checking for Encryption for Website Connections
  • 61. 1 Mozilla Firefox Google Chrome 2 3 4 Checking for Encryption for Website Connections
  • 62. ▪ Poor grammar ▪ Lots of typos ▪ Trying very hard to convince you to open attachment, click on link, or reply without enough detail ▪ May appear to be from known person (rely on trust & innocence) Signs of a Phishing Attack
  • 63. ▪ Don’t be too trusting of people ▪ Always be suspicious & alert ▪ An e-mail with your friend’s name & info doesn’t have to come from him/her ▪ Look for signs of phishing attacks ▪ Don’t open attachments unless you expect them ▪ Scan for viruses before opening attachments ▪ Don’t click links in e-mail. Directly type in browser using known & trusted URLs ▪ Especially cautioned if ask for passwords, bank accounts, credit card numbers, social security numbers, etc. Ways to Protect against Phishing
  • 65. ▪ Malicious software - Any code with intentional, undesirable side effects ▪ Virus ▪ Worm ▪ Trojan ▪ Spyware ▪ Logic Bomb/Time Bomb ▪ Backdoor/Trapdoor ▪ Rootkit ▪ Botnet Malware
  • 66. ▪ Virus ▪ Propagating malware that requires user action to propagate ▪ Infects executable files, data files with executable contents (e.g. Macro), boot sectors ▪ Worm ▪ Self-propagating malware ▪ Trojan ▪ A legitimate program with additional, hidden functionality Malware
  • 67. ▪ Spyware ▪ Trojan that spies for & steals personal information ▪ Logic Bomb/Time Bomb ▪ Malware that triggers under certain conditions ▪ Backdoor/Trapdoor ▪ A hole left behind by malware for future access Malware
  • 68. ▪ Rogue Antispyware ▪ Software that tricks or forces users to pay before fixing (real or hoax) spyware detected ▪ Rootkit ▪ A stealth program designed to hide existence of certain processes or programs from detection ▪ Botnet ▪ A collection of Internet-connected computers that have been compromised (bots) which controller of the botnet can use to do something (e.g. do DDoS attacks) Malware
  • 69. ▪ Installed & updated antivirus, antispyware, & personal firewall ▪ Check for known signatures ▪ Check for improper file changes (integrity failures) ▪ Check for generic patterns of malware (for unknown malware): “Heuristics scan” ▪ Firewall: Block certain network traffic in and out ▪ Sandboxing ▪ Network monitoring & containment ▪ User education ▪ Software patches, more secure protocols Defense Against Malware
  • 70. ▪ Social media spams/scams/clickjacking ▪ Social media privacy issues ▪ User privacy settings ▪ Location services ▪ Mobile device malware & other privacy risks ▪ Stuxnet (advanced malware targeting certain countries) ▪ Advanced persistent threats (APT) by governments & corporations against specific targets Newer Threats
  • 71. Ransomware ระบาดใน Healthcare Top: http://www.healthcareitnews.com/news/more-half-hospitals-hit-ransomware-last-12-months Bottom: http://www.mirror.co.uk/news/uk-news/ransomware-nhs-cyber-attack-live-10409420
  • 74. Medical Device Security Malware & Medical Devices
  • 76. ▪ Most common reason for security bugs is invalid programming assumptions that attackers will look for ▪ Weak input checking ▪ Buffer overflow ▪ Integer overflow ▪ Race condition (Time of Check / Time of Use vulnerabilities) ▪ Running programs in new environments Software Security Adapted from Nicholas Hopper’s teaching slides for UMN Computer Security Class Fall 2006 CSCI 5271
  • 77. ▪ Defense in Depth ▪ Multiple layers of security defense are placed throughout a system to provide redundancy in the event a security control fails ▪ Secure the weakest link ▪ Promote privacy ▪ Trust no one Secure Software Design Principles Saltzer & Schroeder (1975), Viega & McGraw (2000) Adapted from Nicholas Hopper’s teaching slides for UMN Computer Security Class Fall 2006 CSCI 5271 http://en.wikipedia.org/wiki/Defense_in_depth_(computing)
  • 78. ▪ Modular design ▪ Check error conditions on return values ▪ Validate inputs (whitelist vs. blacklist) ▪ Avoid infinite loops, memory leaks ▪ Check for integer overflows ▪ Language/library choices ▪ Development processes Secure Software Best Practices Adapted from Nicholas Hopper’s teaching slides for UMN Computer Security Class Fall 2006 CSCI 5271
  • 79. ▪ Consider a log-in form on a web page Example of Weak Input Checking: SQL Injection ▪ Source code would look something like this: statement = "SELECT * FROM users WHERE name = '" + userName + "';" ▪ Attacker would enter as username: ' or '1'='1 ▪ Which leads to this always-true query: ▪ statement = "SELECT * FROM users WHERE name = '" + "' or '1'='1" + "';" statement = "SELECT * FROM users WHERE name = '' or '1'='1';" http://en.wikipedia.org/wiki/SQL_injection
  • 80. U.S. National Institute of Standards and Technology (NIST) Cybersecurity Framework
  • 82. How to Deal with Security
  • 84. ▪ Respect for Persons (Autonomy) ▪ Beneficence ▪ Non-maleficence ▪ Justice Ethical Principles in Bioethics
  • 85. Hippocratic Oath ... What I may see or hear in the course of treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep myself holding such things shameful to be spoken about. ... http://en.wikipedia.org/wiki/Hippocratic_Oath
  • 86. HIPAA
  • 87. ▪ Health Insurance Portability and Accountability Act of 1996 http://www.gpo.gov/fdsys/pkg/PLAW-104publ191/pdf/PLAW- 104publ191.pdf ▪ More stringent state privacy laws apply ▪ HIPAA Goals ▪ To protect health insurance coverage for workers & families when they change or lose jobs (Title I) ▪ To require establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers (Title II: “Administrative Simplification” provisions) ▪ Administrative Simplification provisions also address security & privacy of health data U.S. Health Information Privacy Law http://en.wikipedia.org/wiki/Health_Insurance_Portability_and_Accountability_Act
  • 88. ▪ Title I: Health Care Access, Portability, and Renewability ▪ Title II: Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform ▪ Requires Department of Health & Human Services (HHS) to draft rules aimed at increasing efficiency of health care system by creating standards for use and dissemination of health care information HIPAA (U.S.)
  • 89. ▪ Title III: Tax-Related Health Provisions ▪ Title IV: Application and Enforcement of Group Health Plan Requirements ▪ Title V: Revenue Offsets HIPAA (U.S.)
  • 90. ▪ HHS promulgated 5 Administrative Simplification rules ▪ Privacy Rule ▪ Transactions and Code Sets Rule ▪ Security Rule ▪ Unique Identifiers Rule ▪ Enforcement Rule HIPAA (U.S.)
  • 91. ▪ Covered Entities ▪ A health plan ▪ A health care clearinghouse ▪ A healthcare provider who transmits any health information in electronic form in connection with a transaction to enable health information to be exchanged electronically ▪ Business Associates Some HIPAA Definitions
  • 92. ▪ Protected Health Information (PHI) ▪ Individually identifiable health information transmitted or maintained in electronic media or other form or medium ▪ Individually Identifiable Health Information ▪ Any information, including demographic information collected from an individual, that— ▪ (A) is created or received by a CE; and ▪ (B) relates to the past, present, or future physical ▪ or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and— ▪ (i) identifies the individual; or ▪ (ii) with respect to which there is a reasonable basis to believe that the information can be used to identify the individual. Some HIPAA Definitions
  • 93. ▪ Name ▪ Address ▪ Phone number ▪ Fax number ▪ E-mail address ▪ SSN ▪ Birthdate ▪ Medical Record No. ▪ Health Plan ID ▪ Treatment date ▪ Account No. ▪ Certificate/License No. ▪ Device ID No. ▪ Vehicle ID No. ▪ Drivers license No. ▪ URL ▪ IP Address ▪ Biometric identifier including fingerprints ▪ Full face photo Protected Health Information – Personal Identifiers in PHI
  • 94. ▪ Establishes national standards to protect PHI; applies to CE & business associates ▪ Requires appropriate safeguards to protect privacy of PHI ▪ Sets limits & conditions on uses & disclosures that may be made without patient authorization ▪ Gives patients rights over their health information, including rights to examine & obtain copy of health records & to request corrections HIPAA Privacy Rule http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
  • 95. ▪ Timeline ▪ November 3, 1999 Proposed Privacy Rule ▪ December 28, 2000 Final Privacy Rule ▪ August 14, 2002 Modifications to Privacy Rule ▪ April 14, 2003 Compliance Date for most CE ▪ Full text (as amended) http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/ adminsimpregtext.pdf HIPAA Privacy Rule http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
  • 96. ▪ Some permitted uses and disclosures ▪ Use of PHI ▪ Sharing, application, use, examination or analysis within the entity that maintains the PHI ▪ Disclosure of PHI ▪ Release or divulgence of information by an entity to persons or organizations outside of that entity. HIPAA Privacy Rule
  • 97. ▪ A covered entity may not use or disclose PHI, except ▪ with individual consent for treatment, payment or healthcare operations (TPO) ▪ with individual authorization for other purposes ▪ without consent or authorization for governmental and other specified purposes HIPAA Privacy Rule
  • 98. ▪ Treatment, payment, health care operations (TPO) ▪ Quality improvement ▪ Competency assurance ▪ Medical reviews & audits ▪ Insurance functions ▪ Business planning & administration ▪ General administrative activities HIPAA Privacy Rule
  • 99. ▪ Uses & disclosures without the need for patient authorization permitted in some circumstances ▪ Required by law ▪ For public health activities ▪ About victims of abuse, neglect, or domestic violence ▪ For health oversight activities ▪ For judicial & administrative proceedings ▪ For law enforcement purposes ▪ About decedents HIPAA Privacy Rule
  • 100. ▪ Uses & disclosures without the need for patient authorization permitted in some circumstances ▪ For cadaveric organ, eye, or tissue donation purposes ▪ For research purposes ▪ To avert a serious threat to health or safety ▪ For workers’ compensation ▪ For specialized government functions ▪ Military & veterans activities ▪ National security & intelligence activities ▪ Protective services for President & others ▪ Medical suitability determinants ▪ Correctional institutions ▪ CE that are government programs providing public benefits HIPAA Privacy Rule
  • 101. ▪ Control use and disclosure of PHI ▪ Notify patients of information practices (NPP, Notice of Privacy Practices) ▪ Specifies how CE can use and share PHI ▪ Specifies patient’s rights regarding their PHI ▪ Provide means for patients to access their own record ▪ Obtain authorization for non-TPO uses and disclosures ▪ Log disclosures ▪ Restrict use or disclosures ▪ Minimum necessary ▪ Privacy policy and practices ▪ Business Associate agreements ▪ Other applicable statutes ▪ Provide management oversight and response to minimize threats and breaches of privacy Responsibilities of a CE From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
  • 102. ▪ Individually identifiable health information collected and used solely for research IS NOT PHI ▪ Researchers obtaining PHI from a CE must obtain the subject’s authorization or must justify an exception: ▪ Waiver of authorization (obtain from the IRB) ▪ Limited Data Set (with data use agreement) ▪ De-identified Data Set ▪ HIPAA Privacy supplements the Common Rule and the FDA’s existing protection for human subjects HIPAA & Research From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
  • 103. ▪ De-identified Data Set ▪ Remove all 18 personal identifiers of subjects, relatives, employers, or household members ▪ OR biostatistician confirms that individual cannot be identified with the available information ▪ Limited Data Set ▪ May include Zip, Birthdate, Date of death, date of service, geographic subdivision ▪ Remove all other personal identifiers of subject, etc. ▪ Data Use Agreement signed by data recipient that there will be no attempt to re-identify the subject Research Data Sets From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
  • 104. ▪ Assure the CE that all research-initiated HIPAA requirements have been met ▪ Provide letter of approval to the researcher to conduct research using PHI ▪ OR, Certify and document that waiver of authorization criteria have been met ▪ Review and approve all authorizations and data use agreements ▪ Retain records documenting HIPAA actions for 6 years IRB’s New Responsibility From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
  • 105. ▪ Establishes national standards to protect individuals’ electronic PHI that is created, received, used, or maintained by a CE. ▪ Requires appropriate safeguards to ensure confidentiality, integrity & security of electronic PHI ▪ Administrative safeguards ▪ Physical safeguards ▪ Technical safeguards HIPAA Security Rule http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
  • 106. ▪ Timeline ▪ August 12, 1998 Proposed Security Rule ▪ February 20, 2003 Final Security Rule ▪ April 21, 2005 Compliance Date for most CE ▪ Full Text http://www.hhs.gov/ocr/privacy/hipaa/ administrative/securityrule/securityrulepdf.pdf HIPAA Security Rule http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/index.html
  • 107. ▪ The HIPAA Security Rule is: ▪ A set of information security “best practices” ▪ A minimum baseline for security ▪ An outline of what to do, and what procedures should be in place ▪ The HIPAA Security Rule is not: ▪ A set of specific instructions ▪ A set of rules for universal, unconditional implementation ▪ A document outlining specific implementations (vendors, equipment, software, etc.) HIPAA Security Rule: Meaning From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
  • 108. ▪ The HIPAA Security Rule is designed to be: ▪ Technology-neutral ▪ Scalable (doesn’t require all CEs to apply the same policies) ▪ Flexible (allows CEs to determine their own needs) ▪ Comprehensive (covers technical, business, and behavioral issues) HIPAA Security Rule: Meaning From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
  • 109. ▪ Many rules are either Required or Addressable ▪ Required: ▪ Compliance is mandatory ▪ Addressable: ▪ If a specification in the Rule is reasonable and appropriate for the CE, then the CE must implement ▪ Otherwise, documentation must be made of the reasons the policy cannot/will not be implemented, and when necessary, offer an alternative HIPAA Security Rule: Meaning From a teaching slide in UMN’s Spring 2006 Health Informatics II class by Dr. David Pieczkiewicz
  • 110. ▪ Breach notification ▪ Extension of complete Privacy & Security HIPAA provisions to business associates of covered entities ▪ New rules for accounting of disclosures of a patient’s health information New in HITECH Act of 2009
  • 111. ▪ Conflicts between federal vs. state laws ▪ Variations among state laws of different states ▪ HIPAA only covers “covered entities” ▪ No general privacy laws in place, only a few sectoral privacy laws e.g. HIPAA Health Information Privacy Law: U.S. Challenges
  • 112. ▪ Canada - The Privacy Act (1983), Personal Information Protection and Electronic Data Act of 2000 ▪ EU Countries - EU General Data Protection Regulation (GDPR) ▪ Australia - Privacy Act of 1988 Health Information Privacy Law: Other Western Countries
  • 113. ▪ General Data Privacy Law ▪ There exists general law protecting privacy of all types of information (financial, educational, health, etc.) ▪ Sectoral Data Privacy Law ▪ Each sector (e.g. health sector) has its own information privacy laws without a general law Two Systems of Privacy Laws
  • 114. Pros & Cons General Data Privacy Law ▪ Pros: Covers all types of information with uniform standard of protection ▪ Cons: May not be flexible for specific requirements in each industry or for each type of information (e.g. health) Sectoral Data Privacy Law ▪ Pros: Protections specific to each type of information (e.g. health information) or nature of each industry ▪ Cons: Not covering other types of information or those kept by other organizations outside the sector, and no uniform standard of protections
  • 115. How to Deal with Security