Hogan Lovells Digital Health brochure 2024 - Flipbook - Page 31
Our privacy and cybersecurity experts
provide strategic advice on structuring
clinical trials to comply with data
protection requirements across the
globe. We advise clinical trial sponsors,
sites, and technology companies on
privacy and security compliance,
including development of mobile
apps and other technologies for use in
research studies, privacy policies, backend security for app and research data
bases, and incident preparedness and
response. We also work with companies
on data governance and uses of data in
the research context and beyond.
Our health care and reimbursement
experts provide advice and assistance
on structuring research budgets and
interacting with physicians so that you
can be con昀椀dent in your compliance
with U.S. Medicare fraud and abuse
laws, equivalent requirements in EU
Member States, international anticorruption laws, and other applicable
legal rules. In addition, our product
liability practice provides practical
advice in structuring clinical trials
to avoid liability, including risk
from clinical trial injury claims
and litigation.
Our FDA medical device and
pharmaceutical experts leverage decades
of institution knowledge to advise
companies on how FDA regulations
apply to their digital health solutions
during clinical investigations and
commercialization. Each intended use
(e.g., stand-alone solution, companion
tool, research only tool) comes with its
own unique regulatory responsibilities
and dictate how the digital product can
be used during a clinical investigation
and marketed. The FDA team uses their
regulatory and scienti昀椀c acumen to help
companies position their digital health
tools for e昀昀ective integration into their
business platform.
We are also here to support your
business when di昀케cult situations arise.
Our global investigations practice and
regulatory experts work closely with
companies in urgent and high pressure
situations. Drawing on our experience
in a variety of complex investigations,
we will guide you through internal
investigations of all kinds, including
those involving fraud, bribery, or
corruption allegations that can arise
from interacting with public o昀케cials in
high-risk jurisdictions, as well as from
potential data breaches or cyberattacks
that may jeopardize clinical trial data
and company assets.
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