2021 LS&HC Horizons - Flipbook - Page 34
The uncertain waters of transferring health data across the Atlantic
The lawful cross-border transfer of EU health
data is now complex, and in some cases,
impossible. In July 2020, in case referred to as
Schrems II, the Court of Justice of the European
Union (CJEU) invalidated the U.S.-EU Privacy
Shield and questioned the validity of the
Standard Contractual Clauses. Together, these
were the two most common means that health
and life sciences organizations had previously
leveraged to transfer personal data from the EU
to countries like the United States.
Since then, organizations have been scrambling
to respond. Meanwhile, EU regulators are
issuing guidance with no easy solutions. For
example, the European Data Protection Board
(EDPB) released a road map for compliance
by July 2021, which requires significant effort
by companies to assess, analyze, and map
transfers and implement measures to address
the requirements outlined by the CJEU in the
Schrems II decision.
The effects of the decision are acutely felt by
EU health care organizations working with
U.S. life sciences and technology companies.
For example, the Schrems II decision led to the
challenge of whether the French government
may lawfully engage Microsoft to host the
French Health Data Hub (HDH). The HDH
is a platform that would pull together public
health databases to facilitate research and
other projects. Multiple legal challenges and
contradictory decisions from authorities
ultimately led the French government to decide
to transfer the HDH to a French or European
platform within two years, primarily due to fear
of mass surveillance by the U.S. government.
As a result, international health data transfers
lack certainty at a time when data needs to
flow to address the pandemic and to allow for
future breakthroughs in medical science and
patient care. Fortunately, with careful analysis
of U.S. and EU laws, this uncertainty can often
be overcome to enable the data sharing that the
post-pandemic world will need.
Partner, Washington, D.C.