provide cloud storage and the application
of AI and other technologies, has already
undergone investigation by the Office
of Civil Rights for possible violations of
HIPAA.8 Google also recently succeeded
in opposing a class action lawsuit brought
against it and its partner, UChicago
Medicine, which alleged that patients’
personal health information had been
shared with Google by the hospital without
having been completely de-identified.9
Use of AI in healthcare also poses unique
privacy and security risks on the back end,
as the large amounts of data being stored
create vulnerabilities to cyberattack.
The growth of AI and big data in health
care is straining the margins of HIPAA,
which passed when the internet was in
its infancy. As more providers integrate AI
into practice, and partnerships with tech
firms become increasingly commonplace,
health privacy law is likely to undergo rapid
changes.
Medical Malpractice
Lawsuits
AI is imperfect, and algorithms make
mistakes. When a provider relies on an
inaccurate algorithm to make a diagnostic
or treatment decision that results in
patient injury, who is liable? Today, AI in
cancer care and health care generally is
10 DALLAS MEDICAL JOURNAL • October 2021
assistive and is intended to be coupled,
first and foremost, with clinical judgment.
This means that overreliance on AI could
be the basis for a medical malpractice
claim.10 The assistive nature of current
AI has also meant that courts have been
hesitant to use products liability approaches
to find the software developer liable for
patient harm.11 As use of AI and machine
learning becomes the standard of care,
however, this is likely to change. Indeed,
it is possible to imagine a near future
where a provider adopts liability by failing
to follow recommendations produced by an
algorithm.
Likewise, hospitals and health systems
could be held liable for adopting AI without
implementing proper training and protocols,
but the same institution could be
held liable for failing to adopt AI that had
become the standard of care. As AI becomes
increasingly standard and reliable,
it is even possible that the AI itself could
be sued.
These legal issues are sure to be tested
in coming years, as integration of AI into
everyday clinical practice increases, and as
the attitudes of the general public adjust
to those changes. Already, a recent study
found that potential jurors are sympathetic
to clinicians who make use of AI—study
participants were less likely to find a physician
who accepted the recommendations
of AI liable for malpractice than a physician
who did not adopt the recommendations
of AI.12
Conclusion
AI in health care is estimated to become
a $36.1 billion market by 2025.13 The developments
wrought by this massive investment
are certain to have an important—perhaps
game-changing—role in the future of
cancer care. The law will likely continue to
struggle to maintain pace with technological
innovation—but by staying alert to regulatory
momentum, privacy considerations, and
liability exposure, health care professionals
can make wise decisions about integrating
AI into their practice. DMJ
Our articles and alerts are provided for
informational purposes only. For ethical
reasons, our attorneys cannot—outside of an
attorney-client relationship—answer specific
questions that would be legal advice.
Brandon Kulwicki is an attorney and
Caitlin Bell-Butterfield is a law clerk with
Hall, Render, Killian, Heath & Lyman, P.C.,
the largest health care-focused law firm in
the country. Please visit the Hall Render
Blog at http://blogs.hallrender.com/ for
more information on topics related to health
care law.
References:
1 FDA Authorizes Marketing of First Device that Uses Artificial
Intelligence to Help Detect Potential Signs of Colon Cancer, U.S.
Food & Drug Admin., (Apr. 9, 2021) https://www.fda.gov/newsevents/
press-announcements/fda-authorizes-marketing-first-device
uses-artificial-intelligence-help-detect-potential-signs-colon.
2 Using AI to Predict Breast Cancer and Individualize Care, MIT
News, (May 7, 2019) https://news.mit.edu/2019/using-aipredict
breast-cancer-and-personalize-care-0507.
3 Guosheng Liang et al., The Emerging Roles of Artificial Intelligence
in Cancer Drug Development and Precision Therapy, 128
Biomedicine & Pharmacotherapy 11025 (2020).
4 Google to Establish Minnesota Office as Projects with Mayo
Clinic Expand and Mature, Health Care IT News (Feb. 18, 2021),
https://www.healthcareitnews.com/news/google-establishminnesota
office-projects-mayo-clinic-expand-and-mature.
5 Digital Health Center of Excellence, U.S. Food & Drug Admin.,
https://www.fda.gov/medical-devices/digital-health-centerexcellence
(updated July 9, 2021).
6 Digital Health Precertification (Pre-Cert) Program, U.S. Food &
Drug Admin, https://www.fda.gov/medical-devices/digital-healthcenter
excellence/digital-health-software-precertification-pre-certprogram
(updated May 6, 2021).
7 Viz.ai Receives New Technology Add-on Payment for Stroke AI
Software from CMS, viz.ai, https://www.viz.ai/press-release/
viz-ai-receives-new-technology-add-on-payment-renewal-for-strokeai
software-from-cms (accessed Sept. 3, 2021).
8 Rob Copeland & Sara E. Needleman, Google’s ‘Project
Nightingale’ Triggers Federal Inquiry, Wall Street J. (Nov.
12, 2019), https://www.wsj.com/articles/behind-googlesproject
nightingale-a-health-data-gold-mine-of-50-million-patients
11573571867.
9 Dinerstein v. Google, No. 19 C 4311 (Dist. Ct. Ill. Sept. 4,
2020).
10 Kevin Tobia et al., When Does Physician Use of AI Increase
Liability? 62 J. Nuclear Med. 17 (2021).
11 See, e.g., Mracek v Bryn Mawr Hosp., 610 F Supp 2d, 401
(E.D. Pa. 2009).
12 Id.
13 Jennifer Bresnick, Artificial Intelligence in Healthcare Spending
to Hit $36B, Health IT Analytics (Dec. 28, 2018), https://
healthitanalytics.com/news/artificial-intelligence-in-healthcarespending
to-hit-36b.