Privacy and AI Heatmap for 2026: What Device & Drug Makers Should Watch
Privacy and artificial intelligence (AI) regulation and enforcement are intensifying globally. This article discusses what device and drug manufacturers should anticipate in 2026 regarding these evolving regulations.
Regulatory Landscape Overview
At the forefront are sweeping changes in privacy and AI regulations, particularly in Europe and the United States. Key areas of focus include:
- GDPR Reforms: The European Commission has proposed a package of reforms known as the “Digital Omnibus” to streamline the General Data Protection Regulation (GDPR), AI Act, Data Act, NIS2, and ePrivacy Directive.
- U.S. Privacy Enforcement: There is an ongoing emphasis on the sharing of personal data without adequate consent and security breaches.
Big Changes to GDPR, AI Act, and Other EU Data Regulations
The proposed reforms aim to simplify compliance costs and include several significant changes:
- Revised Definition of Personal Data: A more precise definition may affect how companies classify and handle data.
- Longer Breach Notification Timelines: With narrower triggers for notifications, companies may need to adjust their response strategies.
- Single-entry Point Breach Reporting: This could streamline the process for reporting breaches across jurisdictions.
- Reduced Obligations for High-risk AI Developers: This may encourage innovation while balancing regulatory oversight.
Where is U.S. Privacy Enforcement Headed?
In the U.S., privacy enforcement is expected to concentrate on:
- Third-party Data Sharing: New state laws, including California’s regulations on automated decision-making, are set to take effect.
- Data Breaches: Continued enforcement against security lapses will be a priority, especially with new regulations coming into force in states like Indiana and Oregon.
State Privacy Laws Continue to Lead the Way
State legislatures are actively addressing emerging privacy issues, with states such as California, Connecticut, and Montana implementing laws to protect “neural data.” This includes:
- Identification of Sensitive Personal Data: States are defining identifiable data regarding brain and nervous system activity as sensitive.
- Legislative Efforts: Ongoing efforts will likely continue as states adapt to the implications of new technologies.
Online Tracking Technologies
The enforcement of online tracking technologies, including cookies and scripts, is a key focus area. More state laws are anticipated to come into effect in 2026, which will bolster enforcement activities.
Federal AI Policymaking
A recent executive order threatens to withhold federal funding if state AI legislation contradicts federal policy, particularly regarding algorithmic discrimination provisions in the Colorado AI Act. This tension highlights the complexities of navigating federal and state regulatory landscapes.
Preparing for 2026: Recommendations for Drug and Device Makers
To navigate these regulatory changes, drug and device manufacturers should:
- Engage with Experts: Collaborate with privacy and AI specialists to build robust governance programs.
- Conduct Audits: Regularly review compliance strategies to stay aligned with evolving regulations.
- Evaluate Website Configurations: Ensure tools comply with the latest online tracking regulations.
- Strengthen AI Governance Policies: Align policies with applicable laws and industry best practices.
Companies that proactively address these challenges will not only mitigate risks but also enhance their market position and foster trust with customers and partners.
