The Journal of mHealth Vol 1 Issue 2 (Apr 2014) | Page 15

Industry News

New US Bill Seeks to Remove
the FDA from the Digital Health
Equation
Controversial legislation to reduce
the regulatory burden for healthtech entrepreneurs has been recently
introduced in the Senate.
The Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014 was
proposed by Senators Angus
King (I-Maine) and Deb Fischer
(R-Nebraska). In a similar manner to
the SOFTWARE Act from October
of 2013, the bill proposes removing
authority from the Washington D.C.
regulators who currently oversee
health IT, notably via the Food and
Drug Administration (FDA).
Supporters of the bill have suggested
that it would free up the FDA to
focus on medical devices that represent a higher risk to patient safety
rather than “low risk” health IT or
“digital health” technologies. At a
time when we have finally seen the

FDA begin to clarify their position on
digital health (with the publication of
their final guidance on Mobile Applications and Guidance), this proposed
bill will surely generate new debate
and questions over the way in which
the sector can be best regulated.
The proposed legislation references
the FDA guidance stating that The
Food and Drug Administration has:
“...sought to expand its enforcement
discretion by regulating the dynamic
mobile health and mobile application
market through the sub-regulatory
guidance, ‘Final Guidance on Mobile
Medical Applications’, issued by the
Food and Drug Administration on
September 25, 2013. In so doing, the
Food and Drug Administration has
set aside economic impact analysis
and failed to defer to Congress’ stated
preference under the Food and Drug
Administration Safety and Innovation Act (Public Law 112–144) that

the agency make recommendations
to Congress about a new risk-based,
regulatory framework.”
The bill further extends this argument in claims that: “The current
Food and Drug Administration
structure for regulating health care
technology was conceived in an era
of discreet devices and wired connections that ill-suit the new environment of nimble applications that
often are run wirelessly and hosted
on the Internet. The role that the
Food and Drug Administration has
taken in regulating such technology
exceeds the role Congress expected
the agency to take.”
The text continues to state that:
“Consumers and innovators need
a new framework for the oversight
of clinical and health software that
Continued on page 14

7 More European Regions
Tackle Care Integration
Seven more European regions turn
to the challenge of providing better
joined-up support to their older population, by bringing social care and
healthcare services closer together.
The BeyondSilos initiative is an EU
co-funded pilot project that allows
providers in seven European regions
to implement and pilot integrated

care services. Up to 10,000 people
in Northern Ireland, Bulgaria, Spain,
Italy, Portugal and Germany are
expected to receive improved services by 2015. The services will be
piloted and evaluated for a period of
two years.
A key role in the services will be
played by different ICT tools (from

home health monitoring to shared
data records) that will be utilised to
enable better cooperation between
care professionals, family members
and those receiving care.
For more information visit the European Commission website: https://
ec.europa.eu/digital-agenda/en/news/7more-regions-tackle-care-integration 

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The Journal of mHealth