LS&HC Horizons 2022 - Flipbook - Page 6
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
6
Precision and Regenerative Medicine
The rising complexities of harnessing genomic data
Genetic and genomic information is facing
a rapidly changing and uncertain regulatory
environment. State legislatures have continued
to enact laws and put forth policies that protect
the privacy of genetic and genomic information
in ways that may complicate its collection and
use. For example, at the state level, Florida and
California, two of the most populous states in
the U.S., enacted laws that may require health
and life science organizations that process
genetic information to reassess their policies
and procedures. At the federal level, and in
response to the evolving genomic research
landscape, the National Institutes of Health
(NIH) is continuing to revise its Genomic
Data Sharing Policy, which sets guidelines for
ensuring appropriate and timely sharing of
genomic research data generated from NIHfunded or conducted research.
The effects of these developments are felt by
various players in the life science industry
who generate, receive, and rely on genetic
information as a core, or even tangential,
part of their business model. For example,
direct-to-consumer (DTC) genetic testing
organizations have direct obligations under
state laws, including notice, consent and
Melissa Bianchi
Partner, Washington, D.C.
consumer rights obligations. Pharmaceutical
companies who may want to obtain genetic
information – from DTC companies or other
entities holding genetic data – to advance
goals of transforming genomic information
into innovative diagnostics and therapies
will need to reassess their deal-making
strategies with such companies. Medical
centers and other organizations participating
in research involving genomic data may also
have new direct or indirect obligations as new
requirements are implemented.
As a result of this ever-evolving regulatory
landscape, health and life science
organizations are tasked with creating flexible
privacy frameworks to maneuver these
developing and increasingly complex regimes.
A thorough understanding of the ways in
which genetic and genomic information may
weave in and out of regulatory frameworks
will help health and life science organizations
to harness the benefits of genetic and genomic
information for much-needed and innovative
treatments and medical technologies.
Fleur Oké
Associate, Washington, D.C.
