regulation. The healthcare company
can then acquire more of the digital
health company later on when
much progress has been made and
the strategic value becomes clear.
We are not advocating sleight-of-hand. There are ways to do
this honestly and legally, keeping
enough distance between the two
parties that the digital health company is allowed to have adequate
freedom. This will require new
ways of thinking about partnerships and business models.
FDA wants to tightly regulate
To be sure, there are individuals at
FDA’s Center for Drug Evaluation
and Research (CDER) who would
like to regulate software more than
companies would like, and in fact
more than their colleagues in the
Center for Devices and Radiological Health (CDRH). But on the
whole, the FDA seems to want to
take a light touch, and that view
is picking-up steam under Commissioner Gottlieb. He has been
adamant that software should be
overseen with a light touch.
Further, over the last few years the
FDA has already down-classified
medical device data systems and
several other forms of software. The
agency is also granting so-called
de novo requests to down-classify
software in other cases, for example
computerized behavioral therapy
devices for psychiatric disorders.
And manufacturers of high risk
medical devices are finding that
digital accessories are no longer automatically subjected to the highest
degree of regulatory control.
On the whole, the FDA
seems to want to take
a light touch, and that
view is picking-up
steam under Commissioner Gottlieb. He is
adamant that software
should be overseen
with a light touch.
Many people at the FDA see great
public health benefits to these technologies. This is frankly the most
excited we’ve ever seen the FDA.
They truly want to foster safe innovation that leads to better clinical
and patient reported outcomes.
But the drug regulators at CDER
and device regulators at CDRH
operate fairly independently, making it difficult to ensure alignment.
This creates undue confusion and
risk. Fortunately, industry leaders
are reaching out to FDA to begin
a dialogue on how we can achieve
better alignment between the two
AN APPROACH TO DRIVING
DIGITAL BY BUSTING THE
REGULATORY MYTHS IN
Let’s say your company comes up
with a creative, out-of-the-box
digital health strategy that promises
to greatly improve care for patients,
but someone in the company raises
a regulatory concern based on what
they’ve heard. Does the project
need to die?
Here’s a pathway that we’ve seen
succeed in overcoming regulatory
CHALLENGE: First, someone
must respectfully challenge the
doctrine. This can take courage,
and often a trusted third party,
such as a consultant, can effectively
initiate this challenge.
RESEARCH: Get someone
to research it. All law is written.
Anything that isn’t written isn’t
law. It’s opinion. If it turns out that
the doctrine is unwritten opinion,
try to find where the opinion
originated. Some sources are more
credible than others, and above all,
continue to probe deeper if you
hear “because we’ve never done
that” or “that’s how we’ve always
GET CREATIVE: Once you
understand what is written, analyze
whether there are nuances of the
law that can be used to achieve
the objective of the digital health
strategy. Get creative in compliance.
Complex rules mean there is often
a variety of approaches that can
achieve compliance. Keep in mind,
“we can’t” often can be overcome
by implementing new processes or
BENCHMARK: If the law is
too general and doesn’t answer
your specific question, and you
fear the FDA will take a contrary
view, compare notes with your peer
companies at trade associations or
coalitions. Often, one company’s
experience is quite different from
another’s, and rather than base your
strategy on only your company’s
interactions with the FDA, see if
you can base your strategy on the
collective industry’s experience
with the agency.
THE FDA: Evaluate the merits of
seeking the agency’s viewpoint,