HEALTH ALLIES
The potential applications of
machine learning and artificial
intelligence (“AI”) to cancer
prevention, detection, and
treatment are nearly limitless. From
targeting lesion detection during
colonoscopies,1 to individualizing breast
cancer risk assessments,2 to optimizing
chemotherapy regimens,3 AI and machine
learning have already proven useful in
cancer care. And, as partnerships between
clinical research stalwarts and tech giants
make clear,4 progress on discovering and
building out these applications is only just
beginning.
As an increasing number of health care
providers integrate these technologies into
their practices, however, new legal and
regulatory questions emerge. This article
provides a brief introduction to these
emergent questions: How will AI in cancer
care be regulated? How will patient privacy
considerations be addressed? And will using
new technologies expose providers to
heightened levels of liability?
Regulation and
Reimbursement
The FDA is racing to keep up with
medical-technological developments. In
recent years, a new unit dedicated to
digital health was created,5 and the FDA is
piloting a streamlined regulatory model for
digital health software.6 Nevertheless, the
current regulatory framework lags behind
the technology. This regulatory delay
can create legal challenges for health
care providers eager to adopt promising
developments in AI.
As the FDA develops new models for
regulating fast-moving AI technology,
payors are also playing catch-up. In
2020, the Centers for Medicare &
Medicaid Services (CMS) approved the
first reimbursement for an AI-augmented
health service—Viz.ai, software that
identifies signs of a stroke on CT.7 This
groundbreaking rule by CMS opens the
door for additional reimbursement for
services involving AI.
Privacy
The development of AI relies on vast
quantities of data collected from a huge
number of patients. This reliance on
individuals’ health information necessarily
raises questions about whether such
use of data violates the Health Insurance
Portability and Accountability Act of 1996
(HIPAA) and state health privacy laws.
These questions have only just begun to
play out. Google, which has partnered with
a number of health care institutions to
Real Concerns with
Artificial Intelligence
Legal and Regulatory Considerations in the Use
of Artificial Intelligence for Cancer Diagnosis and
Treatment
By Brandon Kulwicki, Attorney,
and Caitlin Bell-Butterfield,
Law Clerk, Hall, Render, Killian,
Heath & Lyman, P.C.
8 DALLAS MEDICAL JOURNAL • October 2021