Regulatory Risks of Wearables in Clinical Trials Are Real (and Avoidable)
Wearables have become indispensable in modern clinical trials, tracking vital signs, capturing real-world evidence, and improving patient engagement from anywhere. But as their use increases, so do the regulatory risks. While wearable devices open the door to faster, more patient-centric research, they also introduce new compliance complexities that sponsors and CROs can’t afford to overlook.
Regulators such as the FDA, EMA, and privacy bodies like those enforcing HIPAA and GDPR are paying close attention to how these devices are used and how the data they collect is managed. Failure to properly address these requirements can lead to protocol violations, costly delays, or even the exclusion of valuable data from regulatory submissions. And when wearable-collected data informs safety or efficacy endpoints, the stakes are even higher.
The risks extend beyond paperwork. Inadequate security safeguards, poor data quality, and unclear device validation protocols can compromise patient safety and undermine confidence in trial results. And yet, these risks are entirely avoidable with the right planning and infrastructure.
That’s why compliance needs to be a foundational consideration that is built into the trial protocol, site training plans, data architecture, and, perhaps most importantly, wearable device selection. Is the device validated? Does it meet the threshold for Software as a Medical Device (SaMD)? Will the data transfer into the EDC securely and in a traceable, audit-ready format?
These questions should be addressed long before first patient in. With thoughtful planning and the right technology, such as an EDC platform purpose-built for compliant remote data capture, sponsors can fully leverage the advantages of wearables without introducing risk.
The bottom line: wearable tech can be a clinical trial accelerator, but only if compliance is baked in from the start.
Breaking Down FDA and EMA Expectations for Wearable Tech
As wearable devices become integral to clinical trials, understanding the regulatory landscape set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is imperative. Both agencies have established guidelines to ensure that data collected via wearables is reliable, secure, and ethically obtained.
What the FDA Expects: Fit-for-Purpose and Risk-Based Evaluation
In its 2023 guidance, the FDA outlines how Digital Health Technologies (DHTs), including wearables, should be utilized in clinical investigations. Key expectations include:
- Fit-for-Purpose Validation: Devices must be validated to ensure they are suitable for their intended use in a specific clinical context. This involves demonstrating that the device accurately and reliably measures the clinical endpoints it purports to assess.
- Risk-Based Approach: The FDA emphasizes a risk-based framework, where the level of regulatory oversight corresponds to the potential risk posed by the device. For instance, a wearable that influences treatment decisions may require more stringent evaluation compared to one used for general monitoring.
- Data Integrity and Security: Ensuring the integrity of data collected remotely is paramount. Sponsors should implement measures to protect data from unauthorized access and ensure its accuracy throughout the trial.’
- Participant Safety and Compliance: The FDA advises that the use of wearables should not compromise participant safety. Additionally, sponsors must ensure compliance with applicable regulations, including obtaining informed consent and adhering to privacy laws.
EMA Requirements: Data Quality, Oversight, and Patient Safety
The EMA’s 2023 guideline focuses on the use of computerized systems and electronic data in clinical trials, emphasizing:
- Good Clinical Practice (GCP) Compliance: Systems used to collect and manage data must comply with GCP principles, ensuring that data is credible and that participants’ rights are protected.
- System Validation: Sponsors are responsible for validating computerized systems to confirm that they perform reliably and consistently. This includes ensuring that data is accurately captured, stored, and retrievable.
- Data Integrity and Confidentiality: Measures must be in place to safeguard data integrity and confidentiality, including access controls and audit trails.
- Risk Management: A risk-based approach should be applied to assess and mitigate potential risks associated with electronic systems and data handling.
Global Privacy Regulations You Need To Know
When wearable devices are used in clinical trials, they often collect sensitive health data that falls under strict privacy regulations. Sponsors and CROs must navigate both U.S. and international laws to ensure compliance and protect participant rights.
Navigating HIPAA for U.S.-Based Studies
In the United States, the Health Insurance Portability and Accountability Act (HIPAA) sets national standards for safeguarding protected health information (PHI). Any individually identifiable health data, such as heart rate, glucose levels, or sleep patterns, collected by wearables in clinical trials is considered PHI. Covered entities and their business associates are required to implement administrative, physical, and technical safeguards, including encryption, access controls, and audit trails, to protect this information.
GDPR Compliance for EU Participants
For trials involving participants in the European Union, the General Data Protection Regulation (GDPR) imposes stringent requirements on the processing of personal data, including health-related information collected by wearables. Key principles include obtaining explicit informed consent, ensuring data minimization, and implementing robust security measures. Organizations must also be prepared to uphold data subject rights, such as the right to access, rectify, or erase personal data. Cross-border data transfers outside the EU are subject to additional safeguards.
Ensuring compliance with both HIPAA and GDPR is vital when integrating wearable technology into clinical trials. Platforms like Crucial Data Solutions’ TrialKit can assist by providing secure data management solutions that align with these regulatory frameworks.
When a Wearable Becomes a SaMD
Not all wearable devices are created equal in the eyes of regulators. The moment a wearable starts performing functions that influence treatment decisions, such as diagnosing a condition or recommending a dosage, it may be classified as a Software as a Medical Device (SaMD). This changes the regulatory playing field significantly.
According to the FDA and International Medical Device Regulators Forum (IMDRF), SaMD refers to software intended to be used for one or more medical purposes that perform these functions without being part of a hardware medical device. Many wearable platforms now incorporate AI-driven analytics or feedback mechanisms that fit this definition.
When a wearable qualifies as a SaMD, sponsors must ensure the device has undergone appropriate validation and regulatory clearance, such as a 510(k) submission or CE marking, depending on the market. Validation must demonstrate not just technical performance, but also clinical relevance and reliability in the context of the trial.
It’s also important to distinguish between hardware and software risks. While a device’s sensor may be stable, the software interpreting that data could introduce error if it’s not thoroughly validated.
How EDC Systems Like TrialKit Support Regulatory Compliance
TrialKit by Crucial Data Solutions is a comprehensive eClinical platform designed to streamline regulatory compliance in clinical trials, particularly when integrating wearable technology. Its robust features ensure data integrity, security, and adherence to global regulations.
Immutable Audit Trails
TrialKit maintains detailed, immutable audit trails, capturing every interaction with study data. This feature is crucial for regulatory inspections, providing a transparent record of data modifications and access.
TrialKit is fully compliant with 21 CFR Part 11, the FDA regulation governing electronic records and signatures. This means the platform includes features such as user authentication, audit trails, and system validations, ensuring that all electronically captured data is both trustworthy and legally equivalent to paper records. This means that study teams can rely on TrialKit to meet these requirements without the need for costly workarounds or add-ons.
Role-Based Access Control
With over 250 configurable role-based permissions, TrialKit allows precise control over who can access specific data. This granular access management supports compliance with regulations like HIPAA and GDPR, ensuring that sensitive patient information is protected.
Secure Data Transfer
TrialKit employs encrypted, secure data transfer protocols, aligning with HIPAA and GDPR standards. This ensures that data collected from wearable devices is transmitted and stored securely, maintaining confidentiality and integrity.
Real-World Use Cases
In decentralized and hybrid trials, TrialKit has demonstrated its effectiveness in integrating wearable data. For instance, in studies utilizing remote patient monitoring, TrialKit facilitated seamless data capture from wearable devices, ensuring compliance and data accuracy. In these cases, TrialKit’s integrated query management system played a key role in ensuring Good Clinical Practice (GCP) compliance by streamlining data verification and discrepancy resolution across decentralized teams. With built-in workflows for resolving queries and documenting corrections, the platform helps maintain data credibility and inspection readiness throughout the trial lifecycle.
Real-Time Monitoring and Compliance Alerts
TrialKit also offers real-time data monitoring and compliance alerts, helping study teams detect anomalies or deviations early – before they escalate into audit findings or protocol violations. This proactive oversight supports continuous compliance and enables rapid intervention when data or device issues emerge.By incorporating these features, TrialKit supports sponsors and CROs in maintaining regulatory compliance while leveraging the benefits of wearable technology in clinical trials.
How To Stay Ahead of Compliance Gaps As Wearable Tech Evolves
As wearable technology becomes more advanced, so too do the regulatory expectations around its use in clinical trials. Compliance can’t be an afterthought; it must be embedded into your trial design, device selection, and data workflows from the start.
Sponsors and CROs can stay ahead by taking a proactive approach. Begin with clear internal SOPs that define how wearable devices are selected, validated, and integrated into your trial ecosystem. Work closely with device manufacturers to obtain up-to-date validation documentation. Consider mock audits or compliance testing prior to launch, so you can identify and fix gaps before they become issues.
Staff training is also essential. Teams need to understand the regulatory implications of using connected devices and be well-versed in handling data that crosses jurisdictions. And as wearable features evolve – especially those that may trigger Software as a Medical Device (SaMD) classification – your processes need to adapt in lockstep.
Choosing the right technology partner can make all the difference. Platforms like TrialKit are built to support secure, compliant data capture from wearable devices. With tools like real-time audit trails, role-based permissions, and encrypted data handling, TrialKit simplifies the path to regulatory readiness while giving you the flexibility to innovate.
If you’re planning to integrate wearables into your next clinical trial, now is the time to lay the groundwork for compliance. Reach out to Crucial Data Solutions to learn how TrialKit can help you stay ahead of evolving regulations and keep your trial on track.
FAQs About Compliance With Wearables
Do wearables used in clinical trials require FDA approval?
Not all wearables need FDA approval, but if a device is used to diagnose, treat, or inform clinical decisions, it may qualify as a medical device, especially if it includes software features. In these cases, FDA clearance (e.g., 510(k)) may be required. The key factor is intended use.
What kind of patient data from wearables is protected under HIPAA?
Any individually identifiable health information (biometric data like heart rate or glucose levels, timestamps, device IDs, or data linked to a participant) is protected. HIPAA requires safeguards like encryption, access controls, and audit logs.
How can sponsors ensure GDPR compliance with wearables?
Sponsors must establish a lawful basis (typically informed consent), clearly communicate what data is collected and how it’s used, minimize data collection, and protect cross-border data transfers. Conducting Data Protection Impact Assessments (DPIAs) is also recommended.
How can EDC systems like TrialKit help with compliance?
TrialKit enforces compliance with features like real-time audit trails, role-based access, and secure, encrypted data transfers. It also integrates with validated wearables for traceable, compliant data workflows.
What are the common pitfalls when using wearables in clinical trials?
Key pitfalls include using non-validated devices, overlooking SaMD rules, weak documentation, poor data integration, and noncompliance with privacy laws. Early planning and experienced partners help mitigate these risks.
