LS&HC Horizons 2023 - Flipbook - Page 27
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Privacy and Cybersecurity
Strategies for wider use of patient-generated health data
Advances in medical and digital health
technologies have improved the ability to
generate large volumes of high-quality patientgenerated health data (PGHD), defined
as health-related data created, recorded,
or gathered by or from patients. While
this has opened the potential to transform
drug development and health care through
increasing reliance on PGHD for regulatory
decisions, wider acceptability of real-world
evidence (RWE) continues to face hurdles.
Medical product and digital technology
developers and their investors should consider
early opportunities for strategic engagement
and partnerships to ensure data generated are
high quality and meet regulatory standards.
Clinical trial-generated and real-world PGHD
(including treatment history, biometric data,
symptoms, and lifestyle habits) can lead to
improved understanding of patient lifestyles
and behaviors, filling in gaps in traditional
clinical trial data, better understanding
real-world safety and benefits, and enabling
interventions that lead to improved outcomes.
Lowell M. Zeta
Partner, Washington, D.C.
FDA and other regulatory authorities continue
to adapt their frameworks to harness PGHD.
For example, in October 2022, FDA launched
the Advancing RWE Program, which provides
sponsors opportunities to engage FDA early
to address the acceptability of RWE-based
approaches even before protocol development
and study initiation. Early coordination
with teams of regulatory and compliance
experts to engage regulators and navigate
evolving frameworks can optimize strategic
planning efforts.
We leverage our deep understanding of
product development, clinical trial design, and
data standards to guide our life sciences and
digital technology clients through challenging
regulatory issues and will continue to closely
track FDA’s focus on PGHD and RWE.
Sally Gu
Senior Associate, Washington, D.C.
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