2021 LS&HC Horizons - Flipbook - Page 28
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Hogan Lovells
Telehealth: The new normal, and here to stay
The events of 2020 brought unprecedented
focus to virtual health solutions. Going forward,
health care providers routinely will reach across
borders using technology to provide medical
services directly to patients and physicians or
other health care providers. Telecommunication
modalities such as e-mail, audio, video
conferencing, and mobile apps are already
facilitating diagnosis, consultation, treatment,
and remote monitoring. Remote second
opinions — whereby a health care provider is
asked by either a clinician or a patient to verify
a diagnosis or treatment from a distance — have
also surged in the international and domestic
medical sectors.
Although the practice of medicine is regulated
across the globe, the practice of telemedicine
does not always fit within the traditional areas
of law and regulation applicable to the medical
profession in a particular state or country.
Where countries do regulate telemedicine,
such laws do not necessarily address the
circumstances in which a foreign physician
sitting outside the country may render remote
services into the country.
• Billing and reimbursement: whether, and
under what circumstances, telehealth
services can be covered and reimbursed by
government and other third party payers
varies. Health care providers that receive
reimbursement for services provided in
a country may then be subject to various
regulatory requirements imposed by
that country.
• Telehealth devices: telehealth services
are made possible thanks to software and
connected devices. Such software may
classify as a medical device. For example,
as of 26 May 2021, the new European
Regulations for medical devices (MDR)
will apply, introducing new classification
rules for medical devices software and
creating new obligations for companies
manufacturing, importing or distributing
medical devices. The design of the solution
must include from the outset the constraints
resulting from medical device regulations.
Other challenging issues include liability
and malpractice, e-commerce regulation,
advertising constraints, intellectual property
protection, and tax compliance.
Telehealth solutions raise myriad complex
topics:
• Practice of medicine: physicians and
institutions that are considered “engaged”
in the practice of medicine in a particular
state or country may have licensure/
registration requirements or face
limitations on the precise services that can
be rendered lawfully from a remote location.
• Privacy and data protection: regulation of
patient medical information and data varies
significantly from country to country and
sometimes from state to state, and use of
genetic information is restricted in some
jurisdictions. Processing health data must
rely on a solid legal ground which will often
be the patient’s consent.
William Ferreira
Partner, Washington, D.C.
william.ferreira@hoganlovells.com
Mikael Salmela
Partner, Paris
mikael.salmela@hoganlovells.com
Brooke Bumpers
Counsel, Washington, D.C.
brooke.bumpers@hoganlovells.com
