Data privacy and security aren’t just regulatory requirements—they’re fundamental elements of sustainable business operations, especially for companies handling sensitive health data. Recently, the stability of the EU-US Data Privacy Framework (DPF), which regulates transatlantic data transfers between the European Union and the United States, has been put into question by political shifts and policy reviews in the US. German industries, in particular, are warning about “devastating consequences” if the framework collapses. Specifically, the campaign has launched a formal review of Executive Order 14086—the foundational legal instrument behind the current EU-US Data Privacy Framework. This Executive Order, enacted by President Biden in 2022, was designed to rebuild transatlantic trust by addressing long-standing European concerns over US surveillance practices, especially those involving bulk data collection by intelligence agencies.
Maintaining a robust and stable framework is particularly crucial in Europe, where data privacy standards significantly impact business continuity, consumer confidence, and international collaboration. A stable framework allows seamless data exchange, supports innovation, and ensures European businesses remain globally competitive while safeguarding the privacy rights of EU citizens.
In this article, we’ll unpack key aspects of EU data privacy laws under GDPR, outline the threats posed by potential changes to the EU-US Data Privacy Framework, and discuss practical mitigation strategies. Additionally, we’ll highlight how specialized data management solutions, such as Thryve Health’s infrastructure, can help businesses navigate these complexities effectively, ensuring compliance and maintaining trust.
Understanding EU Data Privacy Laws
At the core of the EU’s approach to data protection lies the General Data Protection Regulation (GDPR), which sets out strict requirements for the processing of personal data. Key principles include:
- Data Minimization: Organizations must collect only the data necessary for specific purposes.
- Purpose Limitation: Data collected for one reason cannot be repurposed without consent.
- Cross-Border Transfer Restrictions: Transfers of personal data to countries outside the EU must ensure equivalent protection.
- Data Subject Rights: Individuals have the right to access, correct, and request the deletion of their data, among other protections.
The GDPR applies to all organizations that process the personal data of EU residents, regardless of where the organization itself is based. This extraterritorial reach has major implications for companies in the US and elsewhere that serve EU customers.
Evolution of the EU-US Data Privacy Framework
To facilitate legal data flows between the EU and the US, a series of frameworks have been established, each developed to address the growing tension between the EU’s strict data protection standards and the extensive data access powers of US national security agencies:
- Safe Harbor (2000–2015): Initially implemented to bridge differences in privacy protection between the EU and the US, Safe Harbor was invalidated by the European Court of Justice (ECJ) following revelations from the Snowden leaks that exposed US mass surveillance programs. The ECJ concluded that Safe Harbor failed to provide adequate protection for EU citizens’ data.
- Privacy Shield (2016–2020): Formed in response to the Safe Harbor decision, Privacy Shield included stronger commitments from the US government regarding oversight and redress. However, in the landmark “Schrems II” case, the ECJ struck it down as well, citing continued concerns about the lack of judicial redress for EU citizens and the unchecked powers of US intelligence agencies.
- EU-US Data Privacy Framework (2023–present): This third attempt to establish a stable transatlantic data transfer mechanism is built upon Executive Order 14086, issued by the Biden administration. It promises enhanced safeguards, including tighter limitations on US surveillance activities and greater redress mechanisms for EU individuals whose data is processed by US entities.
Central to the Framework’s credibility is the role of the Privacy and Civil Liberties Oversight Board (PCLOB). The PCLOB functions as an independent review body overseeing US intelligence programs to ensure they are conducted in a manner consistent with privacy and civil liberties. The Board’s involvement is crucial for addressing EU concerns about proportionality and necessity in data collection, particularly in the context of national security operations.
However, the Framework’s dependence on executive action rather than codified law leaves it vulnerable to political shifts. Unlike legislation passed by Congress, Executive Order 14086 can be unilaterally amended or rescinded by a subsequent administration—a fragility that is now under the spotlight due to the Trump campaign’s policy agenda.
Potential Threats to the Framework
Recent developments pose a serious and multifaceted risk to the long-term stability of the EU-US Data Privacy Framework, signaling the potential for another regulatory rupture reminiscent of the collapse of Safe Harbor and Privacy Shield:
- Review of Executive Order 14086: The Trump campaign has launched an extensive review of the Biden-era Executive Order that underpins the current Framework. The review is focused on whether the Executive Order unduly restricts the scope of operations for US intelligence agencies, particularly regarding surveillance conducted for national security purposes. Revocation of the order is firmly on the table, and if carried out, would nullify the core legal basis upon which the Framework rests.
- Dismissal and Undermining of PCLOB Members: Reports have emerged suggesting plans to dismiss current members of the Privacy and Civil Liberties Oversight Board (PCLOB)—the independent body tasked with ensuring that surveillance programs respect civil liberties. Removing or replacing these members with political appointees sympathetic to broader surveillance powers would erode the EU’s confidence in the Framework’s ability to constrain intelligence overreach.
- Legal Fragility Due to Executive Nature: Unlike legislative statutes, which require Congressional approval to amend or repeal, Executive Order 14086 is vulnerable to unilateral revocation. The Framework’s reliance on executive discretion rather than codified law means that its provisions can be swiftly dismantled without a legislative process or bipartisan oversight.
These dynamics together contribute to an escalating climate of legal and operational uncertainty. The EU’s insistence on “essential equivalence” in data protection standards means that any decline in US commitments, especially around oversight and recourse, could lead to the ECJ once again striking down the Framework. Therefore, businesses are left in a very unstable position, potentially facing abrupt compliance challenges and the suspension of critical data flows.
Impacts on Businesses and Government Authorities
The potential collapse of the Framework would have far-reaching consequences across legal, operational, and financial aspects for companies conducting business between the EU and the US:
- Increased Legal Complexity: Organizations relying on US-based cloud providers such as AWS, Microsoft Azure, or Google Cloud would be immediately confronted with the need to reassess the legal foundations for their data transfers. Many would need to pivot toward alternative legal mechanisms like Standard Contractual Clauses (SCCs), which often require detailed transfer impact assessments and supplementary measures to withstand regulatory scrutiny.
- Disruption of Data Flows: If the Framework is invalidated and no replacement or interim solution is provided, cross-border data transfers to the US could be suspended overnight. This disruption could break core data pipelines used in sectors such as e-commerce, telemedicine, software-as-a-service (SaaS), and financial services, where real-time transatlantic data processing is mission-critical.
- Operational Delays and Costs: Businesses would likely face months of legal and technical adjustments. This includes revising Data Processing Agreements (DPAs), adapting backend architectures to align with localization strategies, retraining staff on revised data handling protocols, and engaging with regulators to document compliance steps. The financial burden of these transitions could be particularly harsh on small and medium-sized enterprises (SMEs) lacking in-house legal counsel.
- Exposure to Legal Risk: Noncompliance with GDPR’s cross-border transfer rules could lead to enforcement actions, including suspension orders by national data protection authorities and administrative fines of up to €20 million or 4% of global turnover, whichever is higher. Additionally, consumer trust could erode in the face of publicized enforcement actions, compounding reputational risk.
These challenges are particularly important in Germany, where regulators such as the Federal Commissioner for Data Protection and Freedom of Information (BfDI) have shown a willingness to issue rigid guidance and take assertive enforcement action. With German companies historically dependent on US cloud solutions, the stakes are especially high for compliance and strategic resilience.
Role of US Intelligence Agencies
A central concern for the EU has always been the ability of US intelligence agencies to access personal data under national security exemptions. If the Framework is revoked:
- Expanded Access: Agencies such as the NSA and FBI could regain broader data collection powers without meaningful oversight.
- Reduced Recourse: EU data subjects may lose the right to effective legal remedies in US courts.
- Data Sovereignty Risks: The balance of power between privacy rights and surveillance prerogatives would tilt heavily toward the latter.
These developments undermine the trust necessary for cross-border data collaboration, especially in sensitive sectors such as healthcare, finance, and digital health.
Mitigation Strategies for Businesses
Organizations must act swiftly to prepare for potential disruptions by adopting a combination of legal, technical, and operational strategies:
- Standard Contractual Clauses (SCCs)
These are pre-approved legal instruments that can be used to legitimize data transfers, provided that adequate safeguards are implemented.
- Binding Corporate Rules (BCRs)
Multinational companies may opt for BCRs, which establish internal rules for data protection across borders. These must be approved by EU data protection authorities but offer long-term stability.
- Data Localization
Businesses can store and process EU data within the EU or in jurisdictions with equivalent protection, reducing dependency on US-based infrastructure.
- Vendor Diversification
Relying on multiple vendors—including EU-based cloud providers—can help distribute risk and enhance resilience.
- Exit Planning
KPMG and other industry advisors recommend preparing for “exit scenarios” where businesses shift away from transatlantic data transfers. This involves contractual audits, vendor risk assessments, and roadmap development.
How Thryve Supports Compliance and Continuity
As the future of the EU-US Data Privacy Framework hangs in the balance, businesses must prioritize adaptability and long-term resilience in their data infrastructure. Regulatory uncertainty may be a recurring theme, but its stakes have never been higher. That’s why organizations need a partner that not only complies with today’s standards but is built to evolve with tomorrow’s laws.
At Thryve, our mission is to make data privacy a constant, not a question. Our unified API is purpose-built for healthcare and digital health providers navigating strict compliance environments. As regulations change, we ensure our platform evolves accordingly, so our clients stay ahead of legal risk and never have to shoulder the burden of compliance alone.
Here’s how Thryve ensures seamless, secure, and future-ready data handling:
- Seamless Integration with 500+ Data Sources: Connect to a wide range of wearables, devices, and medical sensors—including Apple, Fitbit, Garmin, and more—via one standardized API.
- Harmonized Data Models: Translate diverse metrics (activity, sleep, HRV, and more) into a unified, actionable format for better personalization and analysis.
- Secure Infrastructure: Leverage encrypted, GDPR-compliant architecture with strict data residency and audit capabilities.
- Custom Rules and Triggers: Automate nudges, feedback, and clinical decision support with privacy-aware logic based on individual real-time data.
- Insights Dashboards: Enable practitioners and users to monitor trends, set goals, and visualize health progress with confidence.
With Thryve, compliance is not an afterthought—it’s our foundation. No matter how the regulatory environment evolves, we adapt so you don’t have to.
Book a demo with us today to be ready for tomorrow!
