2021 LS&HC Horizons - Flipbook - Page 27
Life Sciences and Health Care Horizons 2021
27
Digital Health
In the last year, digital health technology has
made great leaps forward as health care sought
to address the needs of patients and providers
during the COVID-19 public health emergency.
Our societies have seen a growing number of
new technologies and innovations being used
during the pandemic, including:
• Remote patient monitoring solutions
• Telehealth platforms
• Wearable sensors used for facilitating
collection of patient data in clinical trials
After some failed attempts to apply laws and
regulations designed for more “traditional”
technology to this sector, the legal and
regulatory landscapes began to evolve
iteratively to address it in a more tailored
manner. As a result, the sector was well
positioned as the COVID-19 pandemic has
forced regulators to allow and even encourage
the adoption of digital health technologies.
Some of these policies will stay; while others will
disappear once we emerge from the pandemic.
Thus companies innovating or leveraging digital
health technologies will need to demonstrate
that they are agile and flexible to adapt to this
evolving regulatory framework.
The coming year promises more developments
– some through exciting partnership in
AI, robotics, telehealth, and new types of
technologies – to address chronic diseases,
mental health, therapy adherence, and support
for aging adults. At the same time, business
models for digital health have not been firmly
established, and digital health companies
face tremendous pressure to demonstrate
their commercial viability. On the other hand,
some countries seek to foster the digital health
environment via support through public
initiatives or first attempts of reimbursement
for digital health applications.
In the months and years ahead, success in
developing and leveraging new digital health
products and services will require a deep
understanding of numerous forces at work, and
a nimbleness in shifting focus as needed to keep
pace with the continued rapid evolution of both
technology and regulation. Effective advocacy
before the relevant regulators and the other
players in the ecosystem, when appropriate, is
also key. Our practice groups are well-versed in
the increasingly complex patchwork of global
privacy regulations, novel reimbursement
models, and evolving paradigms for
demonstrating the safety and effectiveness
of digital health solutions to regulators and
notified bodies, as well as the unique liability
and intellectual property questions that arise
with digital health products. We help clients
daily to navigate strategically so that they can
achieve the promise of these endeavors.
Melissa Bianchi
Partner, Washington, D.C.
melissa.bianchi@hoganlovells.com
Fabien Roy
Partner, Brussels
fabien.roy@hoganlovells.com
Jodi Scott
Partner, Denver
jodi.scott@hoganlovells.com
