Wearable Technology in Healthcare Sector: Regulatory Guidelines

Wearable technology has revolutionised healthcare industry. Wearable technology in healthcare industry is enabling continuous and real-time monitoring, thereby empowering both patients and healthcare providers. They are having a considerable impact on improving lives, by detecting health issues early and supporting doctors with real-time data. Notably, not every wearable healthcare technology is strictly regulated.  However, if the device has a medical claim, namely diagnosis, treatment, or monitoring, it will be considered a medical device. Then, the device has to abide by strict regulatory guidelines. Herein, we have created a detailed guide to help you navigate the regulatory guidelines for wearable technology in healthcare industry.

Wearable technology in healthcare industry: 10 common devices

Wearable healthcare tech devices are electronic gadgets that use sensors to collect and track health-related data. The collected data can be used by patients and providers to monitor health, manage disorders, and improve overall well-being. These devices are beneficial for improving patient outcomes as well as reducing hospital visits and enabling personalized care.

1. Smartwatches with health features: These devices are used to monitor heart rate, blood oxygen levels, irregular rhythms, and even detect falls.
2. Wearable ECG monitors: These devices offer clinical-grade electrocardiogram readings for remotely detecting arrhythmias and other cardiac issues.
3. Fitness trackers: These are used to track steps, sleep patterns, heart rate, and activity levels. Their main application is in general wellness and preventive care.
4. Continuous glucose monitors: These devices help obtain real-time glucose readings for diabetes management without finger pricks.
5. Blood pressure monitors: Worn on wrists, these devices are used to track blood pressure trends over time. Blood pressure monitors aid in hypertension management.
6. Biosensors: These are adhesive patches used to monitor multiple vitals, such as heart rate, respiratory rate, and temperature, used in hospitals and remote care.
7. Smart rings: These compact devices can track sleep, temperature, and heart rate variability. Smart rings are often used for early illness detection.
8. Fall detection and emergency alert devices: These devices are especially useful for elderly. In an event of emergency, they can automatically alert caregivers or emergency service providers.
9. Wearable drug delivery systems: Devices, such as insulin pumps or wearable injectors, which administer medication at set intervals belong to the wearable drug delivery system category.
10. Wearable respiratory monitors: These devices are used mainly by patients with asthma or chronic obstructive pulmonary disease (COPD) to track breathing patterns and detect anomalies.

Need for regulatory guidelines for wearable technology in healthcare sector

Wearable technology in healthcare industry is proving to be beneficial for real time monitoring and early disease detection. They are being used to remotely monitor patients, improve disease management, personalise healthcare, and enhance patient engagement. If the wearable healthcare tech device is used to diagnose, monitor, or treat a condition, it has to be strictly regulated as per guidelines for all other medical devices in the market. Regulatory guidelines for wearable technology in healthcare are vital for patient safety and demonstrating product credibility and quality.

• Device quality and efficacy: Regulatory guidelines are in place for wearable healthcare tech devices to be considered medical devices. These guidelines monitor device quality, efficacy, and safety. Hence, a regulatory compliant device will be safe, effective, and perform as intended. As use and presence of wearable technology in healthcare industry is increasing, they have to be safe and effective. Increasing number of wearable healthcare tech devices are being use for patient care and monitoring. Thus, manufacturers are expected to mandatorily comply with the guidelines.
• Patient safety and trust: Wearable healthcare tech devices may influence medical decisions. Additionally, they often collect sensitive health data. Thus, regulatory guidelines mandate rigorous testing, validation, and risk management before the devices are marketed. Hence, compliance with regulatory guidelines is a mandatory requirement. The regulatory framework is in place to ensure the device will not misread a heart rhythm or deliver inaccurate glucose levels. These errors could lead to serious harm and have detrimental effect on the patient.
• Market access and credibility: Compliance with regulatory guidelines is mandatory to launch your products in the market. Additionally, regulatory compliance demonstrates commitment to patient safety, thereby improving credibility of the product. It demonstrates safety, efficacy, and high-quality of the device. Furthermore, regulatory compliance increases trust of patients, healthcare professionals, and stakeholders in the product. This increases market access and improves the reputation of the product in the market.
• Integration with existing clinical medical devices: Next-gen wearable healthcare tech devices are capable enough to be integrated in the clinical system. These devices have to comply with regulatory guidelines for medical devices to meet the safety standards critical for clinical medical devices. Hence, manufacturers have to ensure their product complies with regulatory guidelines so that they can be used alongside preexisting clinical devices.
• Avoid regulatory sanctions and fines: Wearable healthcare tech devices capable of diagnosis, monitoring, or treatment will have to abide by regulatory guidelines for medical devices. Non-compliance can lead to regulatory sanctions, fines, and even product recalls. This will cause long-term damage to the company’s reputation.
• Patient data privacy and security: Wearable technologies store a lot of personal health information. Regulatory guidelines have data protection standards to help protect against data breaches and misuse. Devices that do not comply with these guidelines could expose users to identity theft or unauthorized data sharing. Hence, wearable devices should comply with all applicable regulatory guidelines.

Different regulatory guidelines for wearable technology in healthcare industry

• In the United States: The U.S. Food and Drug Administration (FDA) monitors and regulates all medical devices in the United States. The FDA has classified medical devices into various classes and different classes have different regulatory guidelines. Depending on your device class, you have to determine whether you will require a 510(k) clearance, De Novo pathway, or a Premarket Approval (PMA). Furthermore, if the wearable tech device contains a software that performs medical functions, it must comply with FDA’s guidelines for SaMD.
• In the EU: Medical devices in the EU must comply with European Union Medical Device Regulation (EU MDR). Wearable healthcare tech devices have to be properly classified as per medical device classification system. If considered medical devices, wearables have to strictly comply with EU MDR. Additionally, the CE certificate has to be mandatorily secured.
• In Canada: Health Canada regulates all medical devices entering the Canadian market. Health Canada has classified medical devices per associated risk. All Class I devices require an MDEL. On the other hand, Class II, III, and IV medical devices require an MDL. Furthermore, Health Canada has issued specific guidance for software-based devices, including wearables, focusing on clinical evidence, risk classification, and cybersecurity. Hence, it is vital to comply with these regulations prior to launching these devices in Canada.
• In India: Central Drugs Standard Control Organization (CDSCO) has formulated strict regulations for all medical devices, including wearable healthcare tech devices. Compliance with the Medical Devices Rules, 2017, is mandatory for all medical devices entering the Indian healthcare industry. Moreover, CDSCO has also classified medical devices into four risk classes depending on the medical device classification system. The type of license required for your wearable device will depend on its device class.

Pharmadocx Consultants: Your trusted regulatory consultant

We have mentioned the regulatory guidelines for wearable technology in healthcare industry in some of the major medical device markets. For a detailed list of guidelines for wearable healthcare tech devices in different countries, email at [email protected] or call/Whatsapp on 9996859227. We will help you easily navigate the various regulatory requirements.