Today’s healthcare ecosystem is always online, always streaming. From wearables measuring heart rate variability in milliseconds to apps collecting mood and behavioral inputs daily, real-time health data is no longer an exception—it’s the standard. But this surge in dynamic data introduces a new kind of responsibility for healthtech founders, developers, compliance teams, and legal officers alike. Recently, there has been a debate over the US and EU data framework shift that we covered in one of our latest posts.
Unlike static health records of the past, real-time health data is fluid, user-controlled, and often collected passively through sensors and mobile devices. This shift has raised the stakes for regulatory compliance, particularly around privacy, consent, and data security. Regulatory bodies worldwide are taking note, tightening definitions of health data and enforcing frameworks like GDPR and HIPAA, with increasing rigor.
So, how can modern health platforms innovate at speed while protecting patients and maintaining legal integrity? The answer lies in building infrastructure that embeds compliance into the data stream itself.
What Legal Compliance Means in 2025
As of 2025, real-time health data is subject to overlapping and evolving legal frameworks. Each region has nuanced requirements:
- GDPR (EU): Biometric and behavioral data fall under "special categories" and require explicit, informed consent. Data subjects must retain control over access, deletion, and purpose limitations.
- HIPAA (US): Applies to covered entities and business associates, mandating safeguards for protected health information (PHI) when transmitted or stored electronically.
Compliance risks in real-time health data include:
- Collecting health signals without a valid legal basis
- Insufficient data minimization or over-collection
- Poor handling of consent withdrawal or data deletion
- Cross-border data transfers without appropriate safeguards
A 2023 coordinated enforcement action by the European Data Protection Board (EDPB) involving multiple national data protection authorities highlighted significant compliance gaps across health and wellness apps. The findings emphasized persistent challenges in ensuring lawful data processing, respecting user rights, and achieving transparency. Healthtech platforms can no longer treat compliance as an extra, it must be embedded into the architecture from the start. For a deeper look into how companies balance legal compliance with digital innovation, see our post on Navigating Data Privacy: Why Companies Struggle with Overcompliance or Risk.
The Challenge of Real-Time Data in Health Infrastructure
Streaming health data from wearables, apps, and sensors creates unique infrastructure demands:
- Volume: Real-time data may generate hundreds of thousands of data points per user per day, encompassing continuous streams of biometric signals like heart rate, respiratory rate, step count, sleep stages, and stress markers. Storing, indexing, and retrieving this high-volume data demands scalable and resilient data architectures, such as time-series databases and cloud-based warehouses optimized for healthcare use.
- Velocity: Updates often arrive every second or faster, requiring low-latency ingestion pipelines that support real-time processing. This enables systems to flag anomalies or generate predictive alerts with minimal delay, a critical capability for applications such as seizure detection or cardiac event prevention. In-memory processing, edge computing, and event-driven architectures become essential components of a responsive system.
- Variability: Data formats and schemas differ across sources—Apple HealthKit may use different timestamp conventions or unit measures than Google Fit, Garmin, or proprietary clinical wearables. Harmonizing this variability requires robust data normalization pipelines, metadata tagging, and crosswalk schemas that ensure interoperability without loss of fidelity.
Building infrastructure for this data flow means navigating the tradeoff between:
- Usability: Systems must provide intuitive, real-time dashboards, actionable feedback loops, and contextual insights for both clinicians and end-users. Visualizations must be customizable based on user roles and device types.
- Security: Implementing end-to-end encryption in transit and at rest, strong authentication protocols (e.g., OAuth2, multi-factor authentication), and immutable audit trails is essential to protect sensitive health data from breaches or unauthorized access.
- Privacy: Effective infrastructure must support contextual consent mechanisms, granular purpose limitation, differential access controls based on user roles, and real-time mechanisms for consent revocation or data export to comply with GDPR and HIPAA mandates.
This complexity is compounded by the need to support integrations with external APIs, medical records systems, and population-level analytics platforms. We explore these integration and standardization challenges in more detail in Fitness Tracker Data Granularity & Unified APIs. Without careful design, these integrations introduce vulnerabilities and compliance gaps.
How to Follow the Regulatory Compliance in Health Care
It’s not enough to encrypt data and display a consent banner. True compliance requires designing ethical, secure systems across every layer of the healthtech stack:
- APIs must offer granular access controls that restrict endpoints based on roles, data types, and clinical context. APIs should support patient-initiated data sharing with third parties and include webhook mechanisms that respond to revoked consent in real time. Token expiration policies and scope validation add additional security layers.
- Mobile apps should avoid storing sensitive data locally whenever possible. They must provide transparent, accessible interfaces for reviewing what data is collected, how it’s used, and who it is shared with. Built-in privacy settings should allow users to modify sharing preferences, request deletion, and view historical consent logs.
- Dashboards used by clinicians or administrators should enforce role-based access, where users only see the data necessary for their tasks. All access events should be logged with timestamps, user IDs, and reasons for access. Dashboards should also include built-in alerts for unusual data patterns or unauthorized access attempts.
Additional principles include:
- Consent Models: Transition from static, one-time checkboxes to dynamic, scenario-specific consent prompts that reflect context (e.g., fitness vs. clinical care). Users should be able to pause or modify data collection at any time.
- Data Minimization: Design systems to collect only the minimum required health data for declared outcomes. For example, don’t collect location or movement data unless directly tied to clinical need or user benefits.
- Ethical Defaults: Default privacy settings should be restrictive, with users explicitly opting into broader data use. Avoid coercive UX patterns and ensure clarity in permissions.
Incorporating these measures not only supports regulatory adherence but also strengthens patient trust, enhances transparency, and future-proofs health platforms for global scalability.
GDPR Compliance Software & Tooling
The complexity of regulatory compliance in healthcare calls for dedicated tooling. GDPR compliance software for healthtech platforms typically includes:
- Consent management systems with audit logs and versioning
- Data flow visualizations to document and monitor how data travels through systems
- Encryption protocols and key management to secure data at rest and in transit
- User access controls tied to identity providers (e.g., OAuth2, SSO)
Thryve, for example, enables:
- Customizable consent screens and re-consent flows
- Partner-level API tokens with restricted access scopes
- Transparent logs of data access events for regulators and internal audits
- Embedded data control tools that allow end-users to request deletion, export, or access records directly from integrated platforms
These tools let companies move fast while staying compliant, avoiding fines, audits, and user churn.
How to Use Compliance as a Competitive Advantage
Legal compliance in the age of real-time health data is no longer a checkbox. It is a strategic asset. Platforms that build consent-driven, auditable, and transparent data infrastructures are better positioned to win trust, scale faster, and launch globally. Thryve’s health data compliance infrastructure is purpose-built for real-time, biometric, and behavioral data streams. With our API, we provide services:
- Seamless Device Integration: Easily connect Oura Ring and over 500 other health monitoring devices to your platform via a single API, eliminating the need for multiple integrations.
- Harmonized Biomarkers: Automatically harmonize biometric data streams, including heart rate, sleep metrics, skin temperature, activity levels, and HRV, making the data actionable and consistent across devices.
- GDPR-Compliant Infrastructure: Ensure full compliance with international privacy and security standards, including GDPR and HIPAA. All data is securely encrypted and managed according to the highest privacy requirements.
Thryve empowers healthtech companies to stay ahead of regulatory change while unlocking the value of real-time data. Whether you're building a digital therapeutic, wellness app, or clinical-grade RPM platform, compliance isn't a blocker—it's a blueprint.
Book a demo with Thryve to follow up with the latest regulatory requirements.
