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FDA EXPANDS OVERSIGHT FOR AI, DIGITAL THERAPEUTICS IN
HEALTHCARE: In an effort to catch up with rapid digital
innovation in the healthcare industry, the US Food and Drug
Administration (FDA) is
expanding its pre-certification program and establishing a
new incubator for digital health technology. The FDA introduced
the pre-certification program in 2017 to streamline the
regulatory process of bringing digital health products to market.
The expansion dovetails with the
FDA’s efforts to increase its
control over new digital health products. While it
will help to accelerate the introduction and marketing of
innovative products, it will also give the FDA oversight of
software solutions that historically sit outside of its
authority, FDA regulation expert Bradley Merrill Thompson
told POLITICO. It could also pave the way for the agency to
gather more insight into these companies’ records and processes —
a potential requirement for the precertification process.
The FDA’s announcement addresses three areas that will impact the
future of healthcare in the US and aims to ensure the regulatory
oversight of the digitization of care delivery.
- Expanding the purview of the pre-certification for
medtech. Many new and existing health products have
multiple functions, some that are covered by the FDA’s
oversight, and some that aren’t. The agency is putting draft
provisions in place that will address the gap in tools that
have multiple functions, and describe how and when the FDA
intends to look at non-regulated functions and services.
- Encouraging and preparing for the development of health
products and services that incorporate artificial intelligence
(AI). AI is increasingly being incorporated into new
health tools and products. The FDA is working to facilitate the
inclusion of AI in digital health tools by looking into how it
can apply its pre-certification program for tools based on AI.
- Exploring how digital health tools and services could
be better integrated with prescription drugs. The use
of data and smartphone apps to complement prescription
medication, known as digital therapeutics, is a fast-growing
segment of health. The FDA is investigating how to best include
these offerings in the pre-certification program with the goal
of adding the framework by the end of 2018. The agency also
launched the Information Exchange and Data Transformation
(INFORMED) incubator that will focus on tools to improve cancer
treatment and drug development.
FITBIT TO USE GOOGLE’S HEALTHCARE CLOUD
OFFERING: Wearables maker Fitbit announced Monday that
it will be using Google’s Cloud Healthcare API to make it easier
for the doctors to access wearable data. Google introduced its
dedicated healthcare cloud offering during the HIMSS 2018
conference in March. The product aims to facilitate health data
interoperability by automating the process of collecting and
storing patient data and then making it easier for physicians to
pull actionable insights gleaned through machine learning
algorithms. For Fitbit, the move will be a step forward in its
efforts to become further entrenched in healthcare delivery. The
company has been looking to the health industry to help generate
revenue as shipments of its fitness trackers falter. Fitbit’s
troves of health data are also becoming increasingly valuable to
payers, research institutions, and hospital networks, looking to
glean consumer health insights. Lastly, although device shipments
fell YoY, Fitbit's community of active users rose 9% YoY during
Q4 2017, from 23 million to more than 25 million users. This is
the second cloud health deal Fitbit has made this year, following
its
acquisition of Twine Health in February. Twine’s
HIPAA-compliant platform connects consumers diagnosed with
chronic illnesses, like diabetes and hypertension, with doctors
and coaches. These healthcare professionals can develop lifestyle
strategies and programs to help patients monitor and manage their
illnesses. The addition of Google’s Cloud Healthcare API and its
machine learning processes will make Fitbit’s health data that
much more valuable to researchers, physicians, and insurers
looking to leverage insights to improve healthcare delivery and
accelerate precision medicine offerings.
AMERICAN WELL ACQUIRES AVIZIA, MOVING INTO HOSPITAL-BASED
TELEMEDICINE: US telehealth provider, American Well is
buying acute care telehealth provider Avizia, the company
announced during the American Telemedicine Association 2018
(ATA2018) conference in Chicago. American Well’s existing
platform connects patients with doctors from a home setting. The
acquisition will provide American Well with an acute care
platform, allowing clients to access doctors and specialists from
around the world within hospitals, meaning the service will be
able to support more urgent care cases. The announcement comes as
American Well accelerates its efforts to broaden the reach of its
telehealth services. In January, the company
partnered with Philips to embed its solutions with Philips
digital health products. And during its January funding round,
American Well received more than $59 million from insurer Allianz
to build its telehealth platform. The company also partnered with
Apple and Stanford Medicine to power the Apple Heart Study.
Telemedicine services have grown rapidly over the past few years
as health systems look to tech to boost hospital efficiency and
drive customer growth and retention. In 2017, around 75% of
US health systems either already were, or intended to implement a
telehealth offering, according to
a survey by Foley & Lardner. That’s a significant shift in
sentiment compared to findings in the first survey in
2014 when 87% of respondents said that patients
wouldn't want virtual care services in 2017. As acquisitions and
expansion efforts increase, we expect 2018 to be the
tipping point for telehealth in the US — by 2023 telehealth
offerings will be used by around 57% of the US population,
representing an annualized growth rate of 75% over the next five
years. 
SMARTPHONE-BASED GP AT HAND IS PLANNING
EXPANSION: Just months after launching in Fulham, UK, GP
at Hand, a smartphone solution that allows patients to
consult with their general practitioner (GP) via a video link, is
planning to expand to two more areas by end of year,
according to Digital Health. Early adoption of the offering
has been strong, and the 24-hour service could eventually provide
more than 3 million patients across the greater London area
access to a video consultation within two hours after a user
inputs their symptoms. Virtual consultations are on track to
become a much larger part of the healthcare system in the UK, not
only because they appear to be popular with patients — in Fulham,
where GP at Hand was
trialed, 90% of patients gave the service a five star
rating, according to the Daily Mail — but also because major
resources are going into building out the digital health
capability. For example, in October the National Health Service
(NHS) launched a £45 million ($59 million) fund that will be
used to launch digital consultation services.
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