Brazilian Healthtech – Neurotechnologies, LGPD and the GDPR’s Long-Arm Effect

Summary
This article explores the ANPD’s 2025 Tech Radar on neurotechnologies and how it reshapes compliance risks for Brazilian healthtechs—especially in M&A contexts involving GDPR exposure. It outlines key regulatory concerns, the GDPR’s extraterritorial impact, major due-diligence red flags, and the essential deliverables investors should require.

Introduction

Brazil’s latest ANPD Tech Radar brings neurotechnologies to the forefront of data-protection compliance, exposing significant risks for healthtech companies and investors. With GDPR’s extraterritorial reach, sensitive data processing, opaque AI, and cross-border transfers, data governance has become a critical M&A due-diligence factor requiring structured reviews and robust contractual safeguards.

Key Compliance Risks Shaping Brazilian Healthtech M&A

Brazil’s Data Protection Authority (ANPD) released its 4th Tech Radar in June 2025, focusing entirely on neurotechnologies—marking the first time the regulator targeted this field so directly. The report explores brain-computer interfaces, advanced wearables, AI-driven cognitive therapies, and predictive diagnostics, highlighting risks far beyond traditional health data processing.

For investors and lawyers working M&A deals in Brazil’s healthtech sector, this Radar signals that data protection is no longer a secondary compliance issue—it is now a major source of legal, reputational, and operational risk.

GDPR’s Extraterritorial Relevance

Many Brazilian healthtechs handle personal data from foreign individuals, particularly Europeans—through expats, medical tourists, cross-border clinical trials, or partnerships with EU-based vendors. When this occurs, GDPR Article 3(2) extends jurisdiction to the Brazilian company, even without any EU establishment.

Main Risks Identified by ANPD (Tech Radar #4)

• Inferring health data without explicit consent
  Example: wearables identifying depression through sleep or stress patterns without informing users.
• Lack of transparency in predictive algorithms
  Black-box AI models making clinical decisions without accessible documentation.
• Cybersecurity vulnerabilities in connected devices
  Neural implants or neurostimulators vulnerable to hacking, with potentially physical consequences.
• Automated processing that impacts human dignity
  Behavioral profiling influencing insurance eligibility, discrimination, or patient autonomy in therapy environments.

GDPR Article 22 prohibits automated decision-making with significant effects unless strict safeguards are implemented—making this a critical risk during due diligence.

Most Common Red Flags in Brazilian Healthtech Due Diligence

No clear legal basis for sensitive data (health, genetic, biometric)

LGPD Impact (Brazil): Breach of LGPD Art. 11
GDPR Parallel (Europe): Art. 9 (special categories)
Practical Recommendation: Require full data-mapping and warranties

Generic or “click-to-accept” consents

LGPD Impact (Brazil): Invalid consent (Art. 7 & 11)
GDPR Parallel (Europe): Art. 6 + 7
Practical Recommendation: Ensure all consents are granular, specific, and revocable

Third-party sharing without processor agreements

LGPD Impact (Brazil): Breach of LGPD Art. 28 & 33
GDPR Parallel (Europe): Art. 28
Practical Recommendation: Verify existence and adequacy of all DPAs

Missing or incomplete ROPA

LGPD Impact (Brazil): Serious regulatory violation
GDPR Parallel (Europe): Art. 30
Practical Recommendation: Make ROPA delivery a closing condition

Non-existent or conflicted DPO

LGPD Impact (Brazil): Non-compliance with ANPD Resolution CD nº 2
GDPR Parallel (Europe): Art. 37–39
Practical Recommendation: Require interview + independence confirmation

No DPIA for high-risk products

LGPD Impact (Brazil): Mandatory (ANPD Res. 15/2023)
GDPR Parallel (Europe): Art. 35
Practical Recommendation: Include pre-closing DPIA audit clause

International transfers without safeguards

LGPD Impact (Brazil): Arts. 33–35
GDPR Parallel (Europe): Arts. 44–50
Practical Recommendation: Verify SCCs (2021/2023) or adequacy status

Real Cases Illustrating the Scale of Risk

• Telepsychology platforms investigated for using automated triage without informed consent or AI transparency.
• ANPD actions against genomics startups due to cross-border transfers without SCCs or DPIAs.
• Outsourced cloud hosting increasing irregular data transfer risks.

Until Brazil receives an EU adequacy decision, SCCs and BCRs remain mandatory for compliant transfers.

Essential Due Diligence Deliverables

A robust data-protection review is now essential in healthtech M&A. Key deliverables include:

• LGPD ↔ GDPR gap analysis
• ROPA and DPIA review
• Sub-processor contract verification
• Mapping of all international transfers
• Privacy-specific warranties and indemnities
• Escrow or holdback for regulatory risk exposure

Conclusion

Data protection is no longer secondary in healthtech M&A—especially when neurodata is involved. With ANPD scrutinizing neurotechnologies and GDPR obligations extending across borders, investors must prioritize structured due diligence and strong contractual safeguards.

FAQ

Is neurodata considered sensitive personal data under the LGPD?

Yes—ANPD treats neurodata as highly sensitive because it reveals cognitive, emotional, and health patterns.

Does GDPR apply to Brazilian companies with no EU presence?

Yes, via Article 3(2), whenever EU data subjects’ information is processed.

Are SCCs still required for Brazil–EU transfers?

Yes, until Brazil receives an EU adequacy decision.

What are the top investor red flags?

Missing DPIAs, unclear legal bases, opaque algorithms, and irregular transfers.