Wearable Tech In Trials
What is Wearable Tech in Clinical Trials?
Wearable technology refers to devices worn by patients or trial participants that continuously or intermittently collect health data—like heart rate, activity, sleep patterns, glucose levels, or ECGs. Examples include smartwatches, fitness bands, glucose monitors, and implantable devices.
In clinical trials, wearables enable real-time monitoring of patient data outside the clinical setting, improve data accuracy, and potentially reduce trial costs. However, they also raise legal questions about data privacy, informed consent, liability, and regulatory compliance.
Key Legal Areas Impacted by Wearable Tech in Trials
Data Privacy and Security: Handling of sensitive health data collected continuously.
Informed Consent: How to ensure participants understand what data is collected.
Product Liability: If the wearable device malfunctions, who is liable?
Regulatory Compliance: Wearables as medical devices may need FDA or EMA approval.
Case Explanations Related to Wearable Tech in Trials
While direct case law specific to wearables in trials is sparse, courts have addressed related technology and data/privacy issues that offer valuable precedents.
Case 1: In re: Google Inc. Street View Electronic Communications Litigation (N.D. Cal. 2013)
Summary: Google’s Street View cars inadvertently collected private Wi-Fi data, including unsecured emails and passwords, raising privacy concerns.
Relevance: This case highlights the importance of data privacy when collecting data using technology without explicit consent. In wearable tech clinical trials, devices collect intimate health data, so similar principles of data protection and informed consent apply.
Outcome & Implication: The court emphasized the need for clear consent and data security measures. For trials, sponsors must ensure participants understand what data is collected and how it will be used, stored, and protected.
Case 2: Spokeo, Inc. v. Robins, 578 U.S. 330 (2016)
Summary: This U.S. Supreme Court case dealt with whether a plaintiff had standing to sue for a violation of a data privacy statute when no actual harm was demonstrated.
Relevance: It shows courts require plaintiffs to demonstrate real harm from data breaches or privacy violations. In wearable tech trials, if participant data is mishandled, plaintiffs must prove harm to claim damages.
Outcome & Implication: Clinical trial sponsors need robust data handling protocols to avoid potential lawsuits and ensure compliance with data privacy laws like HIPAA or GDPR.
Case 3: Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
Summary: The Supreme Court ruled that the FDA’s approval of a medical device preempts state law claims for product defects.
Relevance: Wearable devices used in trials often qualify as medical devices regulated by the FDA. If a wearable device harms a participant, liability claims may be preempted by FDA regulation if the device received premarket approval.
Outcome & Implication: Manufacturers have some protection against state law claims once FDA approval is obtained. However, negligence or other claims might still apply. Trial sponsors must ensure devices comply with regulatory standards.
Case 4: Apple Watch ECG Feature – Regulatory and Legal Challenges
While not a traditional court case, Apple’s introduction of the ECG feature on the Apple Watch triggered regulatory scrutiny and lawsuits.
Relevance: The Apple Watch’s use in detecting heart conditions mirrors wearables in trials for remote monitoring.
Legal Issues:
FDA clearance and compliance.
Potential liability for false positives/negatives.
User informed consent regarding medical accuracy.
Implication: Trials must use devices cleared by regulatory bodies, inform participants about device limitations, and have protocols to manage device errors.
Case 5: Murgia v. CBS Corp., 2020 (Hypothetical/Analogous Case)
A case involving injury caused by reliance on wearable device data in an employment or sports context. It’s analogous to wearables in trials where faulty data could lead to wrong clinical decisions.
Relevance: If wearables give inaccurate data, trial results and patient safety may be compromised.
Legal Principle: Duty of care applies to device manufacturers and trial sponsors to ensure accuracy and reliability.
Implication: Clinical trial protocols should include validation and calibration of wearable devices to minimize errors.
Summary
| Aspect | Case / Principle | Implication for Wearable Tech in Trials |
|---|---|---|
| Data Privacy | Google Street View Litigation | Must obtain clear informed consent and secure data |
| Standing for Privacy Harm | Spokeo v. Robins | Demonstrable harm needed for legal claims |
| Regulatory Preemption | Riegel v. Medtronic | FDA approval can limit liability |
| Medical Accuracy & Liability | Apple Watch ECG controversy | Use approved devices, disclose limitations |
| Device Reliability | Analogous device injury cases | Ensure device validation, duty of care |
Conclusion
Wearable technology offers transformative benefits to clinical trials but comes with complex legal challenges. Learning from existing cases related to data privacy, product liability, and regulatory compliance helps trial sponsors develop robust legal and ethical frameworks to safely integrate wearables.
RELATED Blog
0 comments