ethical & legal issues for health it in thailand's context

Ethical & Legal Issues for Health IT in Thailand’s Context

Nawanan Theera‐Ampornpunt, MD, PhDAugust 23, 2012

Except where citing other works

Leads to patient outcomes, including deaths Provider‐patient relationship threatened by IT? “Rationing” of health care through CDSS Information risks Research ethics Informatics practitioners as “professionals” with specific skills, training, & competencies?

Most common question “Who owns the data?”

Why Important in Informatics?

Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition).

Non‐maleficence “Do no harm”

Beneficence Provide benefits to patients

Justice Fair distribution of benefits, risks & costs

Respect for Autonomy Respect decisions made and rights to make decisions by individual persons

Relevant Ethical Principles

Standard view With uncertainties around new technology, “scientific evidence counsels caution and prudence.”

Evidence & reason determine appropriate level of caution

If such systems improve care at acceptable cost in time & money, there’s an obligation to use it

Follows evolving evidence and standards of care

Appropriate Use of Health IT


Standard view For computer‐assisted clinical diagnosis CDS, human cognitive processes are more suited to complex task of diagnosis than machine, and should not be overridden or trumped by computers.

When adequate CDS tools are developed, they should be viewed and used as supplementary and subservient to human clinical judgment



Fundamental Theorem of Informatics(Friedman, 2009)

Standard view Practitioners have obligation to use tools responsibly, through adequate training & understanding the system’s abilities & limitations

Practitioners must not ignore their clinical judgment reflexively when using CDS.



Health IT “should be used in clinical practice only after appropriate evaluation of its efficacy and the documentation that it performs its intended task at an acceptable cost in time & money”

Qualified (licensed, trained & experienced) health professionals as users

Systems should be used to augment/supplement, rather than replace or supplant individuals’ decision making

Adequate training



Follow standard of care & scientific progress (evidence‐based)

System evaluation is ethically imperative

Ethics for Developers


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

Physical Security System Security

Antivirus, Firewall, Intrusion Detection/Prevention System, Log files, Monitoring

Software Security Network Security Database Security User Security

User account management Education against phishing/social engineering

Encryption

Security Safeguards

Dear mail.mahidol.ac.th Email Account User,

We wrote to you on 11th January 2010 advising that you change the password onyour account in order to prevent any unauthorised account access followingthe network instruction we previously communicated.

all Mailhub systems will undergo regularly scheduled maintenance. Accessto your e‐mail via the Webmail client will be unavailable for some timeduring this maintenance period. We are currently upgrading our data baseand 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 createmore space for new accountsusers. we have also investigated a system widesecurity audit to improve and enhanceour current security.

In order to continue using our services you are require to update andre‐comfirmed your email account details as requested below. To completeyour account re‐comfirmation,you must reply to this email immediately andenter your accountdetails 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

Privacy Safeguards

Image: http://www.nurseweek.com/news/images/privacy.jpg

Security safeguards Informed consent Privacy culture User awareness building & education Organizational policy & regulations Enforcement Ongoing privacy & security assessments, monitoring, and protection

Authentication & Authorization Role‐based access control Two‐factor authentication Audit trails

HIPAA Personal Health Information (PHI)

Any individually identifiable health information about a patient that is created, received, processed, or stored by a health plan, clearinghouse, or provider

Deidentified

Other Security Concepts & Techniques

Health Insurance Portability and Accountability Act of 1996 More stringent state privacy laws apply HIPAAPrivacy Rule

Regulates use & disclosure of protected health information held by covered entities

Covered Entities: Health plans, providers, clearing houses, and their business associates

Protected Health Information (PHI): Any individually identifiable health information about a patient

HIPAA Security Rule Lays out security safeguards required for compliance

Administrative safeguards, Physical safeguards, Technical safeguards

New in HITECHAct of 2009 Breach notification

HIPAA (U.S.)

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

From a slide by David S. Pieczkiewicz for a Health Informatics II class (2006) at the University of Minnesota

Some permitted uses and disclosures Treatment, payment, health care operations Quality improvement Competency assurance Medical reviews & audits Insurance functions Business planning & administration General administrative activities

Under HIPAAPrivacy Rule

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 Data Protection Directive UK ‐ Data Protection Act 1998 Austria ‐ Data Protection Act 2000 Australia ‐ Privacy Act of 1988 Germany ‐ Federal Data Protection Act of 2001

Health Information Privacy Law: Other Western Countries

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

Copyright Act, B.E. 2537 พรบ.ลขสทธ พ.ศ. 2537 And other IP laws (e.g. Patent Act) Important for intellectual property considerations (e.g. who owns the software source code of an in‐house or outsourced system?)

Thai ICT Laws

Not considered professional legal opinion

Computer‐Related Crimes Act, B.E. 2550 พรบ.การกระทาความผดเกยวกบคอมพวเตอร พ.ศ. 2550 Focuses on prosecuting computer crimes & computer‐related crimes

Responsibility of organizations as IT service provider: Logging & provision of access data to authorities

Thai ICT Laws


Electronic Transactions Acts, B.E. 2544 & 2551 พรบ.วาดวยธรกรรมทางอเลกทรอนกส พ.ศ. 2544 และ พรบ.วาดวยธรกรรมทางอเลกทรอนกส (ฉบบท 2) พ.ศ. 2551 Legal binding of electronic transactions and electronic signatures

Security & privacy requirements for Determining legal validity & integrity of electronic transactions and documents, print‐outs, & paper‐to‐electronic conversions

Governmental & public organizations Critical infrastructures Financial sectors Electronic certificate authorities

Thai ICT Laws


No universal personal data privacy law (Draft law has been proposed)

National Health Act, B.E. 2550 พรบ.สขภาพแหงชาต พ.ศ. 2550 “มาตรา 7 ขอมลดานสขภาพของบคคล เปนความลบสวนบคคล ผใดจะนาไปเปดเผยในประการทนาจะทาใหบคคลนนเสยหายไมได เวนแตการเปดเผยนนเปนไปตามความประสงคของบคคลนนโดยตรง หรอมกฎหมายเฉพาะบญญตใหตองเปดเผย แตไมวาในกรณใด ๆ ผใดจะอาศยอานาจหรอสทธตามกฎหมายวาดวยขอมลขาวสารของราชการหรอกฎหมายอนเพอขอเอกสารเกยวกบขอมลดานสขภาพของบคคลทไมใชของตนไมได”

Thai Privacy Laws


The Sanatorium Acts, B.E. 2541 & 2547

พรบ.สถานพยาบาล พ.ศ. 2541 และ พรบ.สถานพยาบาล

(ฉบบท 2) พ.ศ. 2547 ประกาศกระทรวงสาธารณสข ฉบบท 3 (พ.ศ. 2542) เรอง ชนดหรอประเภทของการรกษาพยาบาล การบรการอนของ

สถานพยาบาลและสทธของผปวยซงผรบอนญาตจะตองแสดง

ตามมาตรา 32 (3)

Thai Privacy Laws


คาประกาศสทธของผปวย

“...7. ผปวยมสทธทจะไดรบการปกปดขอมลเกยวกบตนเอง จากผประกอบวชาชพโดยเครงครด เวนแตจะไดรบความยนยอมจากผปวยหรอการปฏบตหนาทตามกฎหมาย

...9. ผปวยมสทธทจะไดรบทราบขอมลเกยวกบรกษาพยาบาลเฉพาะของตนทปรากฏในเวชระเบยนเมอรองขอ ทงน ขอมลดงกลาวตองไมเปนการละเมดสทธสวนตวของบคคลอน

...”

Thai Privacy Laws


The Official Information Act, B.E. 2540 พรบ.ขอมลขาวสารของราชการ พ.ศ. 2540 “เปดเผยเปนหลก ปกปดเปนขอยกเวน”“มาตรา 15 ขอมลขาวสารของราชการทมลกษณะอยางหนงอยางใดดงตอไปน หนวยงานของรฐหรอเจาหนาทของรฐอาจมคาสงมใหเปดเผยกได โดยคานงถงการปฏบตหนาทตามกฎหมาย...ประกอบกน

...

(5) รายงานการแพทยหรอขอมลขาวสารสวนบคคลซงการเปดเผยจะเปนการรกลาสทธสวนบคคลโดยไมสมควร

(6) ขอมลขาวสารของราชการทมกฎหมายคมครองมใหเปดเผย...

...”

Thai Privacy Laws


Official Information Act only covers governmental organizations

“Disclose as a rule, protect as an exception” not appropriate mindset for health information

National Health Act: One blanket provision with minimal exceptions: raising concerns about enforceability (in exceptional circumstances, e.g. disasters)

Health Information Privacy Law: Thailand’s Challenges


No general data privacy law in place Unclear implications from ICT laws (e.g. Electronic Transactions Act)

Governance: No governmental authority responsible for oversight, enforcement & regulation of health information privacy protections

Policy: No systematic national policy to promote privacy protections

Health Information Privacy Law: Thailand’s Challenges


We Need A Better Information Privacy Law That Takes Into Account the Unique Nature of Health Information and the

Various Use Cases & Contingencies in Use & Disclosure

of Health Information in Thailand’s Context

Nawanan Theera‐AmpornpuntNot considered professional legal opinion

From Flickr by Bikoy (Victor Villanueva)

Privacy: The Cultural Aspect

From Flickr by Saikofish

Privacy: The Cultural Aspect

Can the electronic data in EHRs be used in court or for other legal purposes? If so, to what extent and under what legal provisions?

I wrote a personal opinion on this in March 2012. Not a professional legal opinion and only based on Ramathibodi’s context, but would be happy to share.

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ethical & legal issues for health it in thailand's context

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