Introduction
The health technology ecosystem is expanding at a faster rate than any other segment within consumer and medical innovation. From smartwatches and continuous glucose monitors to cardiac telemetry patches, sleep monitoring bands, post-surgery recovery trackers and elder-care remote monitoring systems, the industry has shifted from occasional data collection to continuous and intimate surveillance of the human body. These devices monitor pulse rate, blood pressure, oxygen saturation, temperature, movement patterns and even behavioral markers such as stress levels, sleep depth and lifestyle habits.
As a result, the privacy risks associated with these technologies have grown significantly, and businesses operating in this space are increasingly expected to meet stringent data protection obligations. Organisations engaged in building or deploying health wearables, privacy is no longer a secondary feature. Regulators view these devices as part of a sensitive data ecosystem. Users increasingly expect complete transparency and control over their information. Courts and regulators in several jurisdictions have begun scrutinising the misuse, overcollection of health data as unfair, privacy-intrusive, or deceptive conduct, particularly where continuous monitoring is involved.
Why Health Wearables are Considered Legally Sensitive
Health wearables and remote monitoring tools do not simply record information in discrete intervals. They capture constant streams of physiological and behavioral data. This includes biometric identifiers, detailed health metrics, sleep patterns, movement logs, menstrual health information, stress indicators, calorie burn estimates and even correlations between daily behavior and health outcomes. When combined, such information becomes deeply revealing, and the sensitivity of the data elevates the legal obligations associated with processing it. The ecosystem also differs from traditional medical devices. Many wearables are consumer-oriented and are not always operated within a clinical environment. Their data flows through mobile applications, cloud servers, analytics platforms and third-party integrations.
Each of these touchpoints creates its own security and compliance risks. These risks are amplified because many wearable companies collect more information than required for the core functionality of the device. When such practices are combined with profiling, behavioral predictions or marketing-related repurposing, the risk of regulatory action becomes substantial.
Regulatory Framework and their Applicability
Under the Digital Personal Data Protection Act 2023 (“DPDP Act”), health information may now be treated as high-risk personal data due to its nature, scale, and potential impact on individuals, even though the Act does not formally classify data into “sensitive personal data” categories.
As a result, entities processing such information must follow heightened compliance standards. Consent under the DPDP Act must be free, specific and informed. Wearable companies, therefore, cannot rely on vague or bundled consent models that group multiple data uses together. Users must understand what is being collected, how it will be used and whether it will be shared with any third parties.
The DPDP Act further requires companies to identify a specific purpose for collecting the data and the company must not retain or use more data than is strictly required. Where processing is large-scale, involves continuous monitoring, profiling or use of advanced analytics, the entity may be notified as a Significant Data Fiduciary, triggering additional responsibilities such as independent audits, impact assessments and the appointment of a Data Protection Officer.
International Obligations for Cross Border Health Tech Business
Many wearable companies operate across jurisdictions, making global compliance essential. In the European Union, the GDPR treats health data as special category data, requiring explicit consent and robust security controls. DPIAs become mandatory for large-scale monitoring. In the United States, frameworks such as HIPAA may apply where the wearable forms part of a healthcare service offered by covered entities or their business associates, though many consumer wearables fall outside its scope. Certain jurisdictions, such as the United Kingdom, Singapore and Australia, impose their own privacy and biometric data standards, particularly when cloud hosting or cross-border data transfers are involved.
Core Privacy Requirements for Wearables and Remote Monitoring Devices
- Consent and Control: Consent must be meaningful. Users need clear visibility into what data is collected at the device level and at the application level. Since wearables often operate continuously, organisations must consider mechanisms that reinforce consent over time, such as periodic reminders, dashboards and easily accessible settings. Clear affirmative consent is required for processing health and biometric data, and companies must avoid collecting additional information merely for analytics or future commercial use unless separate consent is obtained.
- Data Minimization and Purpose Limitation: Wearable devices often default to broad “collect everything” models, but privacy requirements expect the opposite. Only data that is necessary for the stated purpose should be collected. The purpose should be clearly specified, such as monitoring cardiac rhythm for medical review, tracking daily steps or supporting post-operative recovery. Any secondary use, such as research, behavioral profiling or insurance-related analysis, requires fresh consent.
- Transparency and User Awareness: Providing transparency can be challenging when device screens are small or when users interact mainly through an app. Layered privacy notice, just in time prompts and easily comprehensible summaries can help bridge this gap. Users must be informed about the presence of AI-driven analytics, predictive scoring, monitoring frequency and any form of automated decision-making or inference generation involved in their health assessment.
- Security Controls and IoT Vulnerabilities: Security is one of the most critical parts of compliance. Wearables often operate with wireless connectivity, limited firmware security and multiple integration points. Companies must therefore implement strong encryption for both data in transit and data at rest. Secure device pairing, strict authentication and protection against unauthorised access are essential. But, vulnerability management, timely firmware updates, continuous security testing and a well-defined incident response framework are non-negotiable expectations in this sector.
Practical Compliance Framework for IoT Health Companies
The following structured approach can help businesses meet their obligations and demonstrate accountability.
- Create a comprehensive data map that identifies all data flows, including device collection, app integration, storage, analytics and cross-border transfers.
- Implement a governance framework that includes privacy by design, security by design and periodic compliance reviews.
- Conduct Data Protection Impact Assessments for all high-risk processing activities, especially continuous monitoring or AI-based analytics.
- Put in place strong contractual arrangements that clearly describe the responsibilities of each entity in the data processing chain.
- Provide users with meaningful choices related to consent, sharing settings, data download options and deletion mechanisms.
AMLEGALS Remarks
Privacy in the health wearable ecosystem is both a legal obligation and a business differentiator. Users trust devices that are transparent, secure and respectful of personal boundaries. Regulators expect companies to adopt proactive compliance measures and embed privacy into the core design of their products. For businesses operating in this space, early involvement of legal and compliance teams can prevent future disputes, reduce regulatory exposure and help create a responsible and trustworthy digital health environment. A mature approach to privacy governance not only protects users but also strengthens the long-term sustainability and credibility of the health tech sector.
For any queries or feedback, feel free to connect with mridusha.guha@amlegals.com or Khilansha.mukhija@amlegals.com