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0:00
Hello. I'm Lucia Savage.
I'm an attorney based in the US,
and I'm delighted to
do this talk today for
Henry Stewart Talks about
US privacy law and
digital therapeutics.
0:14
A little bit about myself.
I'm a board member,
a strategist,
and a senior advisor to
health tech companies.
I'm currently CEO of Savage
Healthcare Strategies.
I am the former
chief privacy and
regulatory officer
at Omada Health.
I am the former chief
privacy officer at
the US Department of Health
and Human Services Office
for the National
Coordinator of Health IT.
That is a big mouthful.
That agency is now called
the Assistant Secretary
for Technology Policy.
I've served as an attorney
across the healthcare system
throughout my career.
0:49
I love talking about
privacy and digital health,
and digital therapeutics
being a subsection
of the digital health
sector in the US,
we'll talk about
that a lot today.
I wanted to give you
a little roadmap
of what we're going to
cover in our hour together.
I'm going to talk
about what the term
digital therapeutic means
in the US in particular.
I'm going to talk
generally about
how digital therapeutics
are regulated from
a privacy perspective
and generally
so that you have a
structure that is going to
follow us through the
rest of the presentation.
I'm going to talk
about privacy and
security regulation that
impacts digital therapeutics.
I'm going to do a deep dive
into our American law,
the Health Information Portability
and Accountability Act,
which has our primary federal
privacy health law in it,
because of how it impacts
digital therapeutics.
We're going to do
some case studies,
which I hope you will
be able to dig into.
Lastly, we're going to talk
about the role of the FDA
relative to the privacy
of digital therapeutics.
The slides are really
there for your reference.
Enjoy listening to me.
I wish we were having
a real conversation.
Hopefully, we can
someday figure out
how to have Q&A about this.
But I'm delighted to be invited
and happy to be with you today.
Alright! Let's get started.
