29 June 2025
Category: Drug Safety | Health Technology |
Digital Health
Written by:
Utkarsha Patil, M.Pharm
Reviewed and Fact-Checked By:
Vikas Londhe, MPharm
Pharmacovigilance is the phase of clinical trials that continues throughout the lifespan of the medicine. The main aim of pharmacovigilance is to collect clinical trial and post-marketing information related to the safety of medicine. To collect this information, pharmaceutical industries rely heavily on doctors and patients to voluntarily report safety information, which, unfortunately, often results in underreporting and delayed identification of adverse drug reactions (ADRs). Additionally, pharmaceutical industries take proactive steps in the form of different support programs through which they collect safety information, but that requires a lot of effort and increases the economic burden. On the other hand, the major drawback of clinical trials is that they do not provide real-world data, as trials are conducted in a very controlled manner.
In recent times, the popularity of wearable health devices is increasing; for example, smartwatches have almost replaced traditional wristwatches; people love to wear them. These smartwatches track the health data of the person without using any additional devices or any effort. Health data like heart rate, blood pressure, beats, oxygen level, step counts, and daily calories burned etc. have been recorded by Fitbit. These features of health devices are very beneficial in tracking any adverse events in patients, specifically cardiology events.
Hence, the landscape is evolving with the arrival of wearable health technology. Devices like these now facilitate continuous, real-time monitoring of physiological parameters, offering an additional, more proactive, and more comprehensive channel to gather safety information. As per one research published in PLOS Digital Health Journal on wearable devices in digital health, which focused on the main functions of these devices that are monitoring, screening, detection, and prediction, these functions closely resemble the basic principles of pharmacovigilance, i.e., monitoring, detecting, assessing, and understanding adverse events.
Benefits of Wearable Technologies
Wearables are becoming powerful health monitoring tools. As most of the devices work on batteries and are charged and worn throughout the day, they provide comprehensive health data continuously. This ability to continuously collect physiological data could start a new era in pharmacovigilance, where safety information can be observed in real-world settings with accuracy.
Real-Time, Round-the-Clock Monitoring: Wearables operate 24/7, capturing even slight changes in vital signs like irregular heartbeats or sudden blood pressure shifts that might go unnoticed. This allows for quicker identification of potential ADRs compared to traditional reporting methods.
Empowering Patients: These devices give users more control over their health. Patients can easily track their symptoms, receive alerts, and share data with healthcare providers, promoting better communication and medication adherence.
Real-World Evidence (RWE): As mentioned above, unlike controlled clinical trials, wearable data reflects what happens in real life. This helps researchers identify long-term or rare side effects across a broader and more diverse population.
Early Intervention: If a wearable detects warning signs, it can trigger a timely medical review. This allows doctors to adjust dosages, switch medications, or recommend other interventions before issues become serious.
Integration of Wearable Health Technology in Pharmacovigilance
Integration refers to the combination of wearable health devices and artificial intelligence (AI) systems to create a smart, responsive ecosystem that continuously monitors drug safety in real time.
How integration can work step by step
Data Collection from Wearables
Devices such as smartwatches, biosensors, fitness bands, or smart patches collect continuous physiological data, like heart rate changes, sleep cycles, ECG, physical activity, temperature, calorie burn, oxygen levels, glucose, etc.
Real-Time Analysis via AI/ML
These raw data channels are pushed into AI-powered platforms (cloud) that use machine learning algorithms to detect patterns or deviations. This analysis might include filtration of the data, identification of any significant patterns, and generation of actionable insights.
The AI continuously learns from population-level data and individual baselines to distinguish between normal variation and potential adverse drug reactions (ADRs).
Example: If a wearable detects repeated nighttime arrhythmias after a patient starts a new antihypertensive drug, the AI may flag this as a safety signal.
Connection with Digital Therapeutic Apps
Health Device Wearables are typically connected to mobile apps
These apps can:
- Notify patients of detected abnormalities
- Mobile apps may ask for symptom confirmation (e.g., “Are you experiencing dizziness or palpitations?”)
- Prompt them to report side effects
- Provide customized health advice or reminders
Automated Reporting & Pharmacovigilance Feedback Loops
- If an ADR is suspected, the platform can generate an automated case report for healthcare providers or regulatory bodies.
- These systems can be connected to electronic health records (EHRs) or pharmacovigilance databases like the FDA’s FAERS or EMA’s EudraVigilance, improving the speed and accuracy of safety signal detection.
Real-World Applications of Wearable & App Integration in Pharmacovigilance
1. Apple Heart Study—Stanford & Apple (Supported by FDA)
Apple, in collaboration with Stanford University, has conducted a study in approximately 500,000 participants to assess whether the Apple Watch can accurately detect atrial fibrillation (AFib), a potentially serious heart rhythm condition.
- The Apple Watch continuously monitors users’ heart rhythms.
- Data was sent to a dedicated app.
- If an irregular rhythm was detected, users received a notification and were connected to a telemedicine consultation and an ECG patch for clinical confirmation.
This kind of continuous monitoring is now being considered for drug-induced arrhythmias, such as those caused by QT-prolonging medications (e.g., antipsychotics, antibiotics).
2. FDA’s Digital Health Software Precertification Program
Many health startups and companies have developed software that tracks various health-related data of individuals. As a result, this software generally functions similarly to medical devices. To address this, the FDA introduced a program based on the concept of Software as a Medical Device (SaMD). Under this framework, the FDA aims to fast-track the approval of trustworthy software and apps that collect, analyze, and act on health data, including those used for pharmacovigilance purposes.
Under this program, the AI-powered health apps are integrated with wearables (like Fitbit or Garmin) that can detect side effects from drugs (e.g., fatigue, arrhythmia, sleep disruption) to accelerate approval. These systems generate automated alerts to clinicians or researchers.
3. Propeller Health’s Bluetooth-connected Inhaler
Propeller Health (ResMed) focuses on digital respiratory health, particularly for conditions like asthma and COPD. Their system integrates Bluetooth-enabled inhaler sensors with mobile health apps to track medication usage patterns and environmental triggers. By analyzing this real-time data, the platform can detect signs of drug overuse, poor disease control, or adverse effects such as tremors and potential indicators of medication toxicity. This continuous monitoring supports pharmacovigilance efforts by identifying drug misuse, ineffectiveness, and side effects more accurately and contributes valuable safety data to regulatory and clinical databases.
4. Stanford University Studies Using Wearables for Vaccine Safety
During the COVID-19 pandemic, Stanford University partnered with Tel Aviv University to monitor post-vaccine side effects using wearable and mobile apps.
How It Worked:
- Participants wore smartwatches and logged symptoms via an app.
- Physiological data like resting heart rate, activity level, and sleep were analyzed for changes after vaccination.
- Helped detect both expected side effects (like fever) and rare ones.
This study showed how digital tools can enhance post-market surveillance for vaccines and could apply to drug safety monitoring as well.
5. Ongoing Clinical Trials Using Wearables for Drug Safety
Many current FDA-registered trials use wearables for pharmacovigilance-related outcomes:
- Trials using continuous glucose monitors (CGMs) to monitor the safety of anti-diabetic drugs.
- Smart patches monitor vitals in cancer patients receiving chemotherapy to detect early toxicity.
Special Considerations for Older Adults
Wearable technology has proven useful, especially for seniors. For example, it’s been used to detect medication-related changes in movement or behavior, such as excessive sedation or fall risk, offering insights into how drugs affect older populations in daily life.
Challenges of Wearable health technology
Despite its clear application in the healthcare system, including pharmacovigilance and clinical trials, this technology has some limitations that may hinder its true potential to be used in real-life settings; some of them are
- 1. Data Accuracy and Validation
- Privacy and Data Security Concerns
- Integration with Clinical and Regulatory Systems
Conclusion
Wearable health technology has laid the groundwork for a smarter and more responsive approach to drug safety. With the ability to collect real-time, significant data directly from users, these tools are turning pharmacovigilance from a reactive and proactive mode to a predictive mode, where users can predict the adverse event in real time. But to truly unlock their full potential, we must address challenges like privacy protection, device integration, and data reliability. If we work on these aspects, wearable-driven surveillance could reshape drug monitoring into something safer, more efficient, and tailored to individual needs.
Reference
Kalisch Ellett LM, Janetzki JL, Lim R, Laba TL, Pratt NL. Innovations in pharmacovigilance studies of medicines in older people. Br J Clin Pharmacol. 2025 Jan; 91(1):66-83. Doi: 10.1111/bcp.16049. Epub 2024 Mar 26. PMID: 38529693; PMCID: PMC11671332.
Jiang N, Mück JE, Yetisen AK. The Regulation of Wearable Medical Devices. Trends Biotechnol. 2020 Feb; 38(2):129-133. doi: 10.1016/j.tibtech.2019.06.004. Epub 2019 Jul 15. PMID: 31320119.
Muniappan S, Jeyaraman M, Yadav S, Applications of Blockchain-Based Technology for Healthcare Devices Post-market Surveillance. Cureus. 2024 Apr 8;16(4):e57881. doi: 10.7759/cureus.57881. PMID: 38725738; PMCID: PMC11079575.
Badnjević A, Pokvić LG, Deumić A, Bećirović LS. Post-market surveillance of medical devices: A review. Technol Health Care. 2022;30(6):1315-1329. Doi: 10.3233/THC-220284. PMID: 35964220.
Canali S, Schiaffonati V, Aliverti A (2022) Challenges and recommendations for wearable devices in digital health: Data quality, interoperability, health equity, fairness. PLOS Digit Health 1(10): e0000104. https://doi.org/10.1371/ journal.pdig.0000104
Wearable Technology in Healthcare: Types, Benefits, and Future of Medical Devices, topflight, https://topflightapps.com/ideas/wearable-technology-in-healthcare/
Kang HS, Exworthy M. Wearing the Future—Wearables to Empower Users to Take Greater Responsibility for Their Health and Care: Scoping Review. JMIR Mhealth Uhealth. 2022 Jul 13;10(7):e35684. doi: 10.2196/35684. PMID: 35830222; PMCID: PMC9330198.
Real-time Analytics and Interoperability in Wearable Health Technology: Revolutionizing Patient Care, ACL digital, https://www.acldigital.com/blogs/real-time-analytics-and-interoperability-wearable-health-technology-revolutionizing-patient
Perez MV, Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation, The New England Journal of Medicine, N Engl J Med 2019;381:1909-1917 DOI: 10.1056/NEJMoa1901183
Apple Heart Study, Stanford Medicine, https://med.stanford.edu/appleheartstudy.html
Stanford Medicine announces results of unprecedented Apple Heart Study, https://www.apple.com/newsroom/2019/03/stanford-medicine-announces-results-of-unprecedented-apple-heart-study/
The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, Sep 2022, US FDA, https://www.fda.gov/media/161815/download
Asthma patients breathe easier with new Bluetooth inhalers, https://www.pbs.org/newshour/health/asthma-patients-breathe-easier-new-bluetooth-inhalers
Chan AHY, Pleasants et al, Digital Inhalers for Asthma or Chronic Obstructive Pulmonary Disease: A Scientific Perspective. Pulm Ther. 2021 Dec;7(2):345-376. DOI: 10.1007/s41030-021-00167-4. Epub 2021 Aug 11. PMID: 34379316; PMCID: PMC8589868.
Guan G, Mofaz M, Qian G, Patalon T, Shmueli E, Yamin D, Brandeau ML. Higher sensitivity monitoring of reactions to COVID-19 vaccination using smartwatches. NPJ Digit Med. 2022 Sep 9;5(1):140. doi: 10.1038/s41746-022-00683-w. PMID: 36085312; PMCID: PMC9461410.
Add a Comment