The Perfect Storm Approaching
For over a decade, pharmaceutical scientific engagement has operat
ed on a simple premise: buy enriched data from brokers, layer on sophisticated targeting, and reach healthcare professionals with surgical precision for medical education, KOL identification, and scientific exchange.
This model powered everything from NPI-level targeting for medical symposiums to complex audience segmentation for clinical research outreach.
That foundation is cracking.
Two regulatory forces are converging to create what Medical Affairs leaders are quietly calling “the data winter” — a period when the third-party data that fuels modern pharma scientific engagement will become scarce, expensive, and legally risky.
Important Regulatory Context
Before diving into privacy law impacts, it’s crucial to understand that pharmaceutical engagement operates within multiple regulatory frameworks simultaneously:
FDA Oversight: All promotional prescription drug advertising and labeling must be submitted electronically to FDA before public distribution. Scientific exchange and non-promotional Medical Affairs communications are generally exempt, but the line is closely monitored.
HIPAA Considerations: While pharmaceutical companies are generally not covered entities under HIPAA, they are indirectly impacted through their interactions with providers, payors, and patients who have HIPAA compliance obligations.
State-Specific Requirements: Some states, like Texas, have extended HIPAA-like protections directly to pharmaceutical manufacturers, creating a patchwork of compliance requirements.
FTC Oversight: Companies handling health information must ensure their disclosure statements are not deceptive under the FTC Act, adding another layer of regulatory complexity.
Force One: California’s Delete Act Changes Everything
In October 2023, California passed SB-362, the California Delete Act, creating the most aggressive data broker regulations in U.S. history.
The timeline is unforgiving:
