This week, Hacking Healthcare™ examines the long awaited and recently agreed upon EU-US Data Privacy Framework. We breakdown what this agreement is, why it is needed generally and for the healthcare sector specifically, and whether or not it is likely to withstand the legal challenges that it is expected to face.

As a reminder, this is the public version of the Hacking Healthcare blog. For additional in-depth analysis and opinion, become a member of H-ISAC and receive the TLP Amber version of this blog (available in the Member Portal.)


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TLP WHITE - 7.27.2023 -- Hacking Healthcare™


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Welcome back to Hacking Healthcare

A New EU-US Data Privacy Framework 

On July 10, 2023, the European Commission adopted its adequacy decision for the EU-US Data Privacy Framework (DPF) which entered into effect immediately. The European press release states that, “The decision concludes that the United States ensures an adequate level of protection – comparable to that of the European Union – for personal data transferred from the EU to US companies under the new framework. On the basis of the new adequacy decision, personal data can flow safely from the EU to US companies participating in the framework, without having to put in place additional data protection safeguards.”[i]

An adequacy decision means that the European Commission has decided that a third country or international organization ensures an adequate level of data protection compared to what such data would be subject to within the EU.[ii] Adequacy decisions were established under the General Data Protection Regulation (GDPR), and as a result, personal data can flow freely from the European Economic Area (EEA), which includes EU member states as well as Norway, Iceland, and Liechtenstein, to a third country without another layer of conditions.[iii]

The adequacy decision regarding the DPF follows a multi-year effort and debate over US intelligence agencies’ ability to access EU citizen data, in which the two prior agreements were annulled by the European Court of Justice. Key to the adequacy decision was the introduction of a means of redress for when EU personal data may have been collected improperly by US intelligence agencies. This process will be handled through the newly created Data Protection Review Court (DPRC). The framework also builds on the Executive Order, ‘Enhancing Safeguards for United States Signals Intelligence Activities’ which included necessity and proportionality controls for data gathering by US intelligence agencies, and addressed concerns raised by the EU Court of Justice.[iv]

So, what exactly does the EU-US Data Privacy Framework do?

  • – Due to the adequacy decision, personal data can flow freely and safely between participating US and EU companies.
  • – US intelligence agencies’ access to data is now limited to what is ‘necessary and proportionate’ to protect national security; agencies will adopt procedures to guarantee oversight of the new privacy standards.
  • – It established a two-tier redress system to investigate and resolve complaints of Europeans on the access of data by US intelligence agencies, which includes the creation of the Data Protection Review Court (DPRC).[v]
  • – It sets obligations for companies processing data transferred from the EU, including the requirement to self-certify that they adhere to the standards through the US Department of Commerce.
  • – It establishes rigorous and layered oversight of signals intelligence activities and ensures compliance with limitations on surveillance activities.[vi]

While the DPF is already in effect, it will be subject to periodic reviews conducted by a team of representatives from the European Commission, European data protection authorities, and US authorities. The first review will begin within a year of the adequacy decision to ensure that all elements of the framework have been fully implemented and are functioning properly.


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