Hogan Lovells Digital Health brochure 2024 - Flipbook - Page 27
Similarly, although payment policies
have been implemented for certain
digital health remote monitoring
services, the agency has imposed
signi昀椀cant restrictions that are likely to
curtail widespread adoption.
Additionally, many of the digital
health applications – especially digital
therapeutics that have been approved
by FDA as prescription products
– require a health care provider to
issue a prescription or order before
a patient can access the product.
Very often, companies will rely on
partnerships with telehealth providers
who can evaluate the patients, and if
appropriate, issue a prescription for
the product. The construct and the
agreements between these parties
requires careful consideration to
avoid pitfalls with issues such as state
regulation of telehealth, requirements
for prescriptions provided via telehealth,
the applicability of state pharmacy and
medical device regulations, and the
corporate practice of medicine.
Often, digital health technologies are
incorporated into a prescription medical
device, which are subject to complex
and varied state licensing requirements
that can attach to the activities of
manufacturers and their distribution
partners. Most state licensing paradigms
were developed to handle prescription
drugs and controlled substances and,
consequently, are not always suitable
for the distribution models used for
prescription medical devices.
We regularly advise clients on
navigating these complex challenges to
bring their products to market.
Looking forward, changes to how
manufacturers and distributors
are licensed are coming that may
a昀昀ect medical devices as states
revise their rules to meet the Drug
Supply Chain Security Act (DSCSA)
(Title II of the Drug Quality and
Security Act), which was enacted to
harmonize rules for drug distribution
across the states by establishing
standards. Because medical devices
are largely regulated under states’
drug licensing authorities, we expect
the impacts of many of the drug
distribution regulations to spill
over to medical devices – including
those incorporating digital health
technologies — possibly resulting
in higher standards or additional
licensure requirements.
Because of the complexity of the
licensing schemes, it is important for
a digital health provider to be able
to identify the right set of licensees
that are required for the distribution
model it has adopted for its products
and also monitor the impact on
medical devices. There may also be an
opportunity as rules are reviewed to
shape how the harmonized proposals
are applied to digital health products.
We understand these players and can
advocate for you to ensure a smoother
commercialization process.
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