APR Sept/Oct 2023 - 33

« INSIDER INSIGHT
sponsors' protocols to be rejected because they used data that is
outside the parameters of a particular trial.
A new data privacy framework program between the United States
and European Union hopes to ease some of these challenges. An
unprecedented adequacy decision, the Data Privacy Framework
(DPF) program aims to provide organizations with reliable means
of transferring personal data between the United States and the
European Union while guaranteeing data protection across all
participating countries. Prior to this decision, data transfer between
the US and EU was all but shut off, forcing researchers to enter into
several transactional clauses before sharing data in a new jurisdiction.
Now, the governments of the US and EU have acknowledged that the
ability to share data is critical, and that it is important to strike the
right balance between protecting citizens and providing data access
in a responsible way to spur innovation. With this program in place,
researchers will be able to conduct clinical trials across international
lines much more easily, leading to studies that are more representative
of the intended patient population and enabling them to spend less
time sifting through international privacy laws to make sure they are
compliant, and more time on advancing medical breakthroughs.
The biggest benefit of this program is the effect it will have on data
quality. A wider population being able to take part in clinical research
will lead to more diverse data sets, which will, in turn, give algorithms
a much better pool of data to be trained with, so that AI-powered
solutions will be able to get it right the first time and have a broad,
equitable impact on all patients, regardless of their background.
Regulating the Future: Setting
Responsible Innovation Standards
The Data Privacy Framework program is a global accomplishment in
data sharing that will have far-reaching impacts on clinical research
and AI development across the world, and back in the United States,
we are taking positive strides in defining what the responsible
development of AI technology looks like. Combined with future
agreements to allow the use of clinical trial data in training sets for
AI, the ability to collect, transfer, and use this trove of data has the
potential to support significant progress in allowing AI to improve
healthcare around the globe.
There has been some recent momentum around the
federal
government's and big tech's commitments to thoroughly vet and
validate algorithms. Seven executives from the country's leading tech
companies recently met with President Biden at the White House to
announce their agreement on several commitments regarding the
sharing, testing and development of new technology. While these
voluntary agreements are a far cry from true AI legislation, they take
an important first step in defining standards in AI development and
data sharing that future regulations can be used to build from. It is
vital that future AI legislation decision-making involves the voices of
all stakeholders, not just big tech companies. Smaller companies who
have been developing AI for decades have valuable key learnings to
share - not only should they have a seat at the table, but they should
be critical drivers of this evolving regulatory conversation.
The potential of AI technology in healthcare has been discussed
for years, and we have now reached a tipping point. Implementing
all of the regulations AI needs to enhance data quality and enable
ethical and impactful innovation will be an evolving process. In order
to truly deliver on the promise of AI-powered technology in clinical
research and care, we must move beyond best practices and enforce
regulations every organization and developer must follow with clear
parameters governing responsible development, data sharing and
transparency into how algorithms were created and how personal
data will be used. Only then will we be able to unlock the true
power of data and witness the full capabilities of AI to create a more
equitable, healthier and safer world.
www.americanpharmaceuticalreview.com |
| 33
»
http://www.americanpharmaceuticalreview.com
APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023
