Privacy and compliance challenges for the health tech sector

1. Navigating a Complex Regulatory Environment

Perhaps the single biggest misconception among emerging health tech companies is underestimating the scope of privacy laws that apply to them. Many assume that compliance is only about the health-specific regulations they know (like HIPAA in the US. or the Medical Device Regulation in the EU) or the law of the country where they are based. In reality data protection and privacy laws have extraterritorial reach – they can apply if you offer apps or wearables in a jurisdiction or collect data from its residents, even if you have no physical presence there.

For example, imagine a health app developer headquartered in Country X who makes a wellness app available globally via app stores. They might be fully aware of their obligations under Country X’s laws, but unaware that they simultaneously have obligations under the privacy laws of every other jurisdiction where their app is downloaded. A small team in one country could inadvertently be violating, Brazil’s LGPD or the EU’s GDPR simply because users in those regions signed up.

Another example: a mood-tracking app that collects information on users’ daily emotional states may not seem “medical,” but mood data reveals mental health status, which is considered sensitive personal data under laws like the GDPR – triggering stricter data protection requirements. We have seen startups surprised to learn that their benign-sounding data (e.g. step counts, heart rate, mood logs) are classified as protected health data in many jurisdictions.

The first step is awareness. As a health tech provider you should ask yourself:

• Can you list every country where your device or app is available for sale or download?
• Do you know where all your users, clients, or patients are located globally? (Your user base may span more regions than you think.)
• For each of those countries, can you name the relevant data protection or privacy law that applies? (e.g. GDPR in Europe, CCPA in California, DPDP Act in India, etc.)
• Under each law, what types of data you handle are considered “personal data” or even more restricted “sensitive” personal data? (This is crucial – many laws single out health/biometric/genetic data for heightened protection.)

If you can’t easily answer the above, it’s a sign to deepen your regulatory mapping. A simple regulatory checklist like this can reveal gaps in your compliance coverage.

Being global means coping with fragmentation in definitions and rules. What counts as “health data” or sensitive personal data differs: the EU GDPR defines any data about health (including inferred data like wellness app readings) as “special category” personal data, while in the US., new laws like Washington’s WMHMDA define “consumer health data” very broadly to include any information that could link to past, present, or future physical or mental health status (even if not collected in a clinical context). Some jurisdictions treat precise location or genetic data as sensitive; others may not. These definitional differences affect what legal basis you need to process the data, whether you need explicit consent, and so forth.

In addition, multiple regimes have a scope that stretches well beyond their own geographical borders. The GDPR and many GDPR-inspired laws (like those in Barbados or Jamaica) have extraterritorial clauses, if you’re offering goods/services to people in their country or monitoring their behavior, or offering services to citizens of their country while they are abroad, their law likely applies[21]. Brazil’s LGPD and India’s DPDP Act also cast a wide net over foreign companies processing local data even inside their borders. Understanding these jurisdictional gotchas is essential to avoid “surprise” liabilities.

Finally, consider data residency and localization requirements. Certain countries mandate that health data be stored locally or impose heavy conditions for exporting it. For instance, UAE’s health data law prohibits the storing or processing of health records outside the UAE without permission[34][18], and China’s regulations require a government security assessment before transferring large volumes of personal or sensitive data abroad. Ignoring these precepts could not only draw fines but also get your app blocked from the country by the relevant authorities.

Practical Tip: Map your data flows against a world map of laws. Identify where your users are and which laws are engaged. This might result in a matrix of obligations – but it will highlight common themes (as we address in the next section) that you can tackle in a unified way. Engaging privacy counsel or specialists in your key markets (EU, US, UK, India, etc.) can help clarify your exposure. As you plan market expansion, bake in regulatory considerations from the start. It’s much easier to incorporate compliance (e.g. add proper consent flows or storage choices) while designing the product than to retrofit them under regulatory pressure later on.

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