This document discusses some of the legal and ethical issues involved in using AI systems like therapist AI and ChatGPT. It outlines that while AI shows promise in areas like information retrieval, diagnosis, and treatment planning, there are also significant risks regarding privacy, bias, lack of explanation for results, and lack of empathy. The document also discusses regulatory issues involving licensure of AI systems, FDA oversight of clinical decision support tools, potential tort liability for harms caused by AI, and whether patients could establish a standard of care for AI. Overall it aims to help mental health professionals minimize ethical risks when using AI tools.
HIPAA Compliant Social Media for ProfessionalsMarlene Maheu
In this webinar, we outline exactly how to protect your business by managing how your employees use social media as healthcare providers. You’ll get concrete examples of how to create effective policies surrounding uses of phones and social media around the office, as well as real life examples of HIPAA breaches that have occurred as a result of improper social media usage.
Use of E-mailing, Texting, and Personal Devices by Health Care Professionals ...Conference Panel
In this internet-savvy world where everything is shared clicks, it gets difficult to safeguard protected health information. You must be well-versed with the concept and the term ‘Protected Health Information. You must know that as per the latest HIPAA rules not anything or everything related to PHI can be shared on the internet.
Although emailing and texting proves a lot more convenient for health care practitioner as well as patients these communication methods have security risks and inherent pitfalls. Implementing e-mail and text solutions in the health care setting is a complex issue and several factors must be addressed.
Basics of HIPAA privacy as to electronic communication devices
Examples of state licensure laws governing protected health information and solving how to apply them to the health care practitioner
This informative webinar begins with the most basic of questions: Does the HIPAA Privacy Rule permit health care providers to use e-mail to discuss health issues and treatment with their patients?
Find out the answer and examine how the privacy rules of HIPAA allow covered entities and health care providers to communicate electronically, such as through e-mail or texting, with their patients and with other health care practitioners, but only provided those health care practitioners apply reasonable safeguards when doing so. This is mandated by federal administrative regulation.
This webinar is thus an advanced overview of the many rules, both by HIPAA at the federal level and in state licensure laws, that govern e-mailing and texting with patients and with other health care practitioners.
Who Should Attend
Health care attorneys
corporate compliance officers in health care
medical records staff of medical offices and health care entities
hospital attorneys
health care practitioners who are covered entities
law enforcement officers in health care compliance
state boards and agencies with jurisdiction over state licenses to practice a health care profession
Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.
7 Tips for Educating Patients/ Clients for Telehealth & Teletherapy Best Prac...Marlene Maheu
This professional training will give concise suggestions for optimally approaching 7 key issues related to client/patient education for safe, effective clinical interventions.
Need CME(s), CNE(s), or CE(s)?
Register for full CME, CNE, or CE credit(s) for multi-modal, 100% online, on-demand telehealth professional training programs. Registration gives you access to slides, handouts, course materials, and course completion certificates for your licensing board: http://telehealth.org/course-catalog.
Read our 700+ no-cost blog posts at https://blog.telehealth.org, and register for one of our 55+ no-cost telehealth newsletters at https://telehealth.org/signup. If you are seeking telehealth-specific vendors to provide technology, visit https://guide.telehealth.org.
Information systems for health decision making - a citizen's perspectiveErdem Yazganoglu
We make health decisions everyday. We get our information from the Internet. As a society we are investing large amounts of funding for the health information systems. In this presentation, I tried to look from the perspective of a citizen and tried bringing a different perspective.
In search of a digital health compass: My data, my decision, our powerchronaki
Knowledge is power. Despite extensive investments in digital health technology, navigating the health system online is challenging for most citizens. Also for eHealth, the “Inverse Care Law” proposed by Hart in 1971, seems to apply. Availability of good medical or social care services and tools online, varies inversely with the need of the population. The low adoption of eHealth services, and persistent disparities in health triggers a call for multidisciplinary action.
Barriers and challenges are not to be underestimated. Culture, education, skills, costs, perceptions of power and role, are essential for multidisciplinary action. This comes together in digital health literacy, which ought to become an integral part to navigate any health system. Patients living with an implanted device or coping with persistent, chronic disease such as diabetes, as well as citizens engaged in self-care, caring for an elderly relative, a neighbor, or their child with illness or deteriorating health, need a digital health compass.
The panel will engage the audience to elaborate on a vision for this personal, digital health compass and drive advancement in health informatics and digital health standards. The transformative power of health data fueled by targeted digital health literacy interventions can be leveraged by open, massive, and individualized delivery. This way, digital health literate, confident patients and citizens join health professionals, researchers and policy makers to address age-related health and wellness changes to shape the emerging precision medicine and population health initiatives.
From a panel in the eHealthweek 2016. http://www.ehealthweek.org/ehome/128630/hl7-efmi-sessions/
Smartphone Apps - Evidence Based Considerations for PsychologyMarlene Maheu
Dr. Maheu offers an introduction to evidence-based apps to be used with smartphones and other portable devices.
The above event is sponsored by the TeleMental Health Institute, Inc. We are the premier professional training site for professionals seeking training in telehealth. Our courses are offered in a state-of-the-art, 100% online learning environment that is fully mobile compatible. Professional training is now available from your desktop of mobile device, 24/7, at your home or office.
To receive our FREE monthly newsletter related to telemental health, telecounseling, online therapy, telepsychology or telepsychiatry and telenursing, send an email to: tmhinews@aweber.com You will also receive notices of our bonuses and discounts for professional training for CEUs and CMEs.
See other offerings at www.telehealth.org
Send questions or comments to us at www.support.telehealth.org
Contact Dr. Maheu to speak at your next workshop or conference at: www.support.telehealth.org
Smart Patient Engagement Solutions for Physical Therapists and Rehabilitation...David Dansereau
My presentation will look at the benefits of harnessing new health technology and mobile health data to improve therapy services, promote wellness and awareness through better patient engagement and help improve medical research. I'll also cover what I believe the future holds for the mHealth industry with respect to rehabilitation and prevention, and what challenges lie ahead for providers that consider adopting these new methods of care delivery.
Note: This is based on my personal experience,interviews and research. Please keep and open mind as this is new territory for all of us!
HIPAA Guidelines and Electronic Communication: What Healthcare Professionals ...Conference Panel
Learn how HIPAA privacy rules permit healthcare providers to communicate electronically with patients and colleagues while maintaining confidentiality. Discover the precautions needed, such as verifying email addresses and limiting information in unencrypted emails. Patients have rights to request alternative communication methods, and healthcare providers must accommodate reasonable requests. Find out how to navigate state licensure laws for additional confidentiality measures. Gain clarity on patient consent and communication practices for electronic communication in healthcare.
Register,
https://conferencepanel.com/conference/emailing-texting-use-of-personal-devices-by-healthcare-professionals
HIPAA Compliant Social Media for ProfessionalsMarlene Maheu
In this webinar, we outline exactly how to protect your business by managing how your employees use social media as healthcare providers. You’ll get concrete examples of how to create effective policies surrounding uses of phones and social media around the office, as well as real life examples of HIPAA breaches that have occurred as a result of improper social media usage.
Use of E-mailing, Texting, and Personal Devices by Health Care Professionals ...Conference Panel
In this internet-savvy world where everything is shared clicks, it gets difficult to safeguard protected health information. You must be well-versed with the concept and the term ‘Protected Health Information. You must know that as per the latest HIPAA rules not anything or everything related to PHI can be shared on the internet.
Although emailing and texting proves a lot more convenient for health care practitioner as well as patients these communication methods have security risks and inherent pitfalls. Implementing e-mail and text solutions in the health care setting is a complex issue and several factors must be addressed.
Basics of HIPAA privacy as to electronic communication devices
Examples of state licensure laws governing protected health information and solving how to apply them to the health care practitioner
This informative webinar begins with the most basic of questions: Does the HIPAA Privacy Rule permit health care providers to use e-mail to discuss health issues and treatment with their patients?
Find out the answer and examine how the privacy rules of HIPAA allow covered entities and health care providers to communicate electronically, such as through e-mail or texting, with their patients and with other health care practitioners, but only provided those health care practitioners apply reasonable safeguards when doing so. This is mandated by federal administrative regulation.
This webinar is thus an advanced overview of the many rules, both by HIPAA at the federal level and in state licensure laws, that govern e-mailing and texting with patients and with other health care practitioners.
Who Should Attend
Health care attorneys
corporate compliance officers in health care
medical records staff of medical offices and health care entities
hospital attorneys
health care practitioners who are covered entities
law enforcement officers in health care compliance
state boards and agencies with jurisdiction over state licenses to practice a health care profession
Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.
7 Tips for Educating Patients/ Clients for Telehealth & Teletherapy Best Prac...Marlene Maheu
This professional training will give concise suggestions for optimally approaching 7 key issues related to client/patient education for safe, effective clinical interventions.
Need CME(s), CNE(s), or CE(s)?
Register for full CME, CNE, or CE credit(s) for multi-modal, 100% online, on-demand telehealth professional training programs. Registration gives you access to slides, handouts, course materials, and course completion certificates for your licensing board: http://telehealth.org/course-catalog.
Read our 700+ no-cost blog posts at https://blog.telehealth.org, and register for one of our 55+ no-cost telehealth newsletters at https://telehealth.org/signup. If you are seeking telehealth-specific vendors to provide technology, visit https://guide.telehealth.org.
Information systems for health decision making - a citizen's perspectiveErdem Yazganoglu
We make health decisions everyday. We get our information from the Internet. As a society we are investing large amounts of funding for the health information systems. In this presentation, I tried to look from the perspective of a citizen and tried bringing a different perspective.
In search of a digital health compass: My data, my decision, our powerchronaki
Knowledge is power. Despite extensive investments in digital health technology, navigating the health system online is challenging for most citizens. Also for eHealth, the “Inverse Care Law” proposed by Hart in 1971, seems to apply. Availability of good medical or social care services and tools online, varies inversely with the need of the population. The low adoption of eHealth services, and persistent disparities in health triggers a call for multidisciplinary action.
Barriers and challenges are not to be underestimated. Culture, education, skills, costs, perceptions of power and role, are essential for multidisciplinary action. This comes together in digital health literacy, which ought to become an integral part to navigate any health system. Patients living with an implanted device or coping with persistent, chronic disease such as diabetes, as well as citizens engaged in self-care, caring for an elderly relative, a neighbor, or their child with illness or deteriorating health, need a digital health compass.
The panel will engage the audience to elaborate on a vision for this personal, digital health compass and drive advancement in health informatics and digital health standards. The transformative power of health data fueled by targeted digital health literacy interventions can be leveraged by open, massive, and individualized delivery. This way, digital health literate, confident patients and citizens join health professionals, researchers and policy makers to address age-related health and wellness changes to shape the emerging precision medicine and population health initiatives.
From a panel in the eHealthweek 2016. http://www.ehealthweek.org/ehome/128630/hl7-efmi-sessions/
Smartphone Apps - Evidence Based Considerations for PsychologyMarlene Maheu
Dr. Maheu offers an introduction to evidence-based apps to be used with smartphones and other portable devices.
The above event is sponsored by the TeleMental Health Institute, Inc. We are the premier professional training site for professionals seeking training in telehealth. Our courses are offered in a state-of-the-art, 100% online learning environment that is fully mobile compatible. Professional training is now available from your desktop of mobile device, 24/7, at your home or office.
To receive our FREE monthly newsletter related to telemental health, telecounseling, online therapy, telepsychology or telepsychiatry and telenursing, send an email to: tmhinews@aweber.com You will also receive notices of our bonuses and discounts for professional training for CEUs and CMEs.
See other offerings at www.telehealth.org
Send questions or comments to us at www.support.telehealth.org
Contact Dr. Maheu to speak at your next workshop or conference at: www.support.telehealth.org
Smart Patient Engagement Solutions for Physical Therapists and Rehabilitation...David Dansereau
My presentation will look at the benefits of harnessing new health technology and mobile health data to improve therapy services, promote wellness and awareness through better patient engagement and help improve medical research. I'll also cover what I believe the future holds for the mHealth industry with respect to rehabilitation and prevention, and what challenges lie ahead for providers that consider adopting these new methods of care delivery.
Note: This is based on my personal experience,interviews and research. Please keep and open mind as this is new territory for all of us!
HIPAA Guidelines and Electronic Communication: What Healthcare Professionals ...Conference Panel
Learn how HIPAA privacy rules permit healthcare providers to communicate electronically with patients and colleagues while maintaining confidentiality. Discover the precautions needed, such as verifying email addresses and limiting information in unencrypted emails. Patients have rights to request alternative communication methods, and healthcare providers must accommodate reasonable requests. Find out how to navigate state licensure laws for additional confidentiality measures. Gain clarity on patient consent and communication practices for electronic communication in healthcare.
Register,
https://conferencepanel.com/conference/emailing-texting-use-of-personal-devices-by-healthcare-professionals
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For a full-service telehealth training segment associated with this topic, see https://telehealth.org/legally-ethically-marketing-your-telehealth-services/
Need CME(s), CNE(s), or CE(s)?
Register for full CME, CNE, or CE credit(s) for multi-modal, 100% online, on-demand telehealth professional training programs. Registration gives you access to slides, handouts, course materials, and course completion certificates for your licensing board: http://telehealth.org/course-catalog.
Read our 700+ no-cost blog posts at https://blog.telehealth.org, and register for one of our 55+ no-cost telehealth newsletters at https://telehealth.org/signup. If you are seeking telehealth-specific vendors to provide technology, visit https://guide.telehealth.org.
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Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
2. Joseph P. McMenamin, MD, JD, FCLM
Joe McMenamin is a partner at Christian & Barton in
Richmond, Virginia. His practice concentrates on digital health
and on the application of AI in healthcare.
He is an Associate Professor of Legal Medicine at Virginia
Commonwealth University and Board-certified in Legal
Medicine.
3. Marlene M. Maheu, PhD
Marlene Maheu, PhD has been a pioneer in telemental health
for three decades.
With five textbooks, dozens of book chapters, and journal
articles to her name, she is the Founder and CEO of the
Telebehavioral Health Institute (TBHI).
She is the CEO of the Coalition for Technology in Behavioral
Science (CTiBS), and the Founder of the Journal for
Technology in Behavioral Science.
6. Preventing
Interruptions
Maximize your learning by:
• Making a to-do list as we go.
• Turning on your camera & join the
conversation throughout this
activity.
• Muting your phone.
• Asking family and friends to stay
away.
We will not be discussing all slides.
7. • Mr. McMenamin speaks neither for any legal client nor for Telehealth.org
• Is neither a technical expert nor an Intellectual Property lawyer.
• Offers information about the law, not legal advice.
• Labors under a dearth of legal authorities specific to AI.
Speaker Disclaimers
8. • Must treat some subjects in cursory fashion only.
• Presents theories of liability as illustrations, conceding nothing as to their
validity.
• Criticizes no person or entity, nor AI.
• In this presentation, neither creates nor seeks to create an attorney-client
relationship with any member of the audience.
Speaker Disclaimers
26. How AI has helped:
1. Personal Sensing (“Digital Phenotyping”)
Collecting and analyzing data from sensors
(smartphones, wearables, etc.) to identify behaviors,
thoughts, feelings, and traits.
2. Natural language processing
3. Chatbots
D’Alfonso, Curr Opin Psychol. 2020;36:112–117.
27. How AI has helped:
4. Machine Learning
Predict and classify suicidal thoughts, depression,
schizophrenia with ”high accuracy”.
U. Cal and IBM, https://www.forbes.com/sites/bernardmarr/2023/07/06/ai-in-mental-health-
opportunities-and-challenges-in-developing-intelligent-digital-therapies/
5. Causation v. Correlation
Better prognosis for pneumonia in asthma patients.
28. How AI has helped:
6. Hallucinations
NEDA’s Tessa: Harmful diet advice to patients with
eating disorders.
7. Generalizability
When training data do not resemble actual data.
Watson and chemo.
6. No compassion or empathy
7. No conceptual thinking
8. No common sense
36. Do We Need to License AI to Use it in
Healthcare?
37. Do We Need to License AI to
Use it in Healthcare?
• Practice of clinical psychology includes but is not limited to: ‘Diagnosis and
treatment of mental and emotional disorders’ which consists of the appropriate
diagnosis of mental disorders according to standards of the profession and the
ordering or providing of treatments according to need.
Va. Code § 54.1-3600
• Other professions have similar statutes across the 50 states & territories.
38. Do We Need to License AI to
Use it in Healthcare?
• Definitions of medicine, psychology, nursing, etc.:
Likely broad enough to encompass AI functions.
• An AI system is not human, but if it functions as a HC professional, some propose
licensure or some other regulatory mechanism.
39. Do We Need to License AI to
Use it in Healthcare?
If licensure needed:
• If so, in what jurisdiction(s)?
• Consider scope of practice.
41. What Does FDA Say About AI in Healthcare?
• Regulatory framework is not yet fully developed.
• Historical: Drug or device maker wishing to modify product submits proposal,
and supporting data; FDA says yes or no.
• FDA recognizes potential for drug development and the impediments that fusty
regulation could erect.
42. What Does Federal Drug Administration (FDA) Say
About AI in Healthcare?
• Concerned with transparency (can it be explained? intellectual property) and
security and integrity of data generated; potential for amplifying errors or biases.
• FDA urges creation of a risk management plan, and care in choice of training
data, testing, validation.
• Pre-determined change control plans.
64. What if AI Recommends Non-standard
Treatment?
• The progress problem: Arterial blood gas monitoring in premature newborns
circa 1990.
• Non-standard advice: Proceed with caution.
The tension between progress and tort law.
73. Does the Law Require the Patient’s
Informed Consent to Use of AI in Health
Care?
74. Does the Law Require the Patient’s
Informed Consent to Use of AI in Health
Care?
• Traditional:
“Every human being of adult years and sound mind has a right to
determine what shall be done with his own body”
Schloendorff v. NY Hospital, 105 N.E. 92 (N.Y. 1914) (Cardozo, J.)
• AI: What disclosures are required?
75. (cont’d)
• Explain how AI works?
What does ‘informed’ mean where no-one knows how black-
box AI works?
• Whether the AI system was trained on a data set representative
of a particular patient population?
• Comparative predictive accuracy and error rates of AI system
across patient subgroups?
• Roles human caregivers and the AI system will play during
each part of a procedure?
76. (cont’d)
• Whether a medical technologist or pharmacist influenced an
algorithm?
• Compare results with AI and human approaches?
What if there are no data?
• What if the patient doesn’t want to know?
• Provider’s financial interest in the AI used?
• Disclose AI recommendations HCP disapproves, or COIs?
77. (cont’d)
• Pedicle screw litigation: Used off-label
At present, nearly all AI is used off-label.
• Investigative nature of the device's use?
Rights of subjects in clinical trials?
• Experimental procedures: “most frequent risks and hazards” will
remain unknown until the procedure becomes established.
89. Who is an Expert?
• Trial Court: Cardiologist not qualified to testify on weight loss drug combo that
proprietary software package recommended because doctor is not a software
expert.
Skounakis v. Sotillo A-2403-15T2 (N.J. Super. Ct. App. Div. Mar. 19, 2018)
(on appeal, reversed)
90. Who is an Expert?
• MD who had performed many robotic surgeries not qualified on causation for
want of programming expertise.
Mracek v. Bryn Mawr Hospital, 363 F. App'x. 925, 926 (3d Cir. 2010) (ED
complicating robotic prostatectomy)
106. Will AI Put Me Out of Work?
• ChatGPT can outperform 1st and 2nd year medical students in
answering challenging clinical care exam questions.
• Law students: Similar.
• But: Probably not.
107. (cont’d)
• John Halamka: “Generative AI is not thought, it's not
sentience.”
• Most, if not all, countries are experiencing severe clinician
shortages.
Shortages are only predicted to get worse in the U.S. until at
least 2030.
108. (cont’d)
• AI-infused precision health tools might well be essential to
improving the efficiency of care.
• AI might help burn-out: ease the day-to-day weariness,
lethargy, and delay of reviewing patient charts.
• The day may come when the SOC requires use of AI.
113. Can AI Detect or Prevent Fraud?
• One large health insurer reported a savings of $1 billion
annually through AI-prevented FWA.
• Fed. Ct App: Company’s use of AI for prior auth and utilization
management services to MA and Medicaid managed care
plans is subject to qualitative review that may result in liability
for the AI-using entity.
US ex re v. Evicore Healthcare MSI, LLC. (2d. Cir., 2022)
116. J. DOE 1 et al. v. GitHub, Inc. et al., Case
No. 4:22-cv-06823-JST (N.D. Cal. 2022):
• Ps: They and class own copyrighted materials made available
publicly on GitHub.
• Ps: Representing class, assert 12 causes of action, including
violations of Digital Millennium Copyright Act, California
Consumer Privacy Act, and breach of contract.
117. Claim:
• Defendants' OpenAI's Codex and GitHub's Copilot generate
suggestions nearly identical to code scraped from public
GitHub repositories, without giving the attribution required
under the applicable license.
118. Defenses:
1. Standing. Did these Plaintiffs suffer injury?
2. Intent: Copilot, as a neutral technology, cannot satisfy
DMCA’s § 1202's intent and knowledge requirements.