- With standards, manufacturers have clearly documented protocols to follow when designing health and medical devices, so that patients can feel more confident in product reliability.
- Standards help enable interoperability by allowing disparate technologies to share information across the end-to-end infrastructure.
- Standards can also help make the devices more secure to help patients feel comfortable using the devices.
Do you know how many steps you took yesterday? What about how many hours you slept continuously last night? If you do, chances are you are using a fitness tracker or some type of monitoring device to collect this data.
More and more people, either healthy or those with chronic conditions, are effectively using digital health devices to play an active role in their healthcare and even collaborate with their physicians to improve their health. For example, by using a digital glucose monitor, a patient can immediately access a patient’s blood sugar level and make the appropriate food choices or medical interventions based on the results.
As digital technologies and infrastructure become more accessible in rural and underserved areas, patients can also have greater access to specialized care and monitoring. For example, if you live three hours away from the nearest cardiologist you may not be able to travel to the office more than once a month for monitoring. Before digital health tools were available, you may have experienced a delay in receiving treatment after an abnormal event. With remote monitoring, you now have access to regular monitoring and can receive an immediate response from a cardiologist within minutes of symptoms — which can be lifesaving.
Personal health devices have the power to make positive changes in individual patient outcomes as well as worldwide progress in reducing health disparity. However, these devices do not operate in a vacuum. The data you collect from the devices need to work with other devices, apps, and platforms. This is where technology standards come in — to allow any device to communicate with any platform in the world, and provide the framework for digital health technology to function in a secure way.
So what are the ways that technology standards can improve our everyday health devices?
1. Standards Help Increase Product Reliability and Consumer Confidence
With increased adoption and usage by providers and patients, the global benefits of personal health devices increase exponentially. Patients and providers are more likely to use devices when they know what to expect and feel confident in the reliability of the devices.
In a highly regulated industry such as healthcare, technology standards can help devices meet the stringent requirements for quality, safety, compatibility, and consistency, which in turn helps patients feel more comfortable about using them. With standards, manufacturers have clearly documented protocols to follow when designing health and medical devices, so that users can access and control their health and medical devices in a uniform way.
For example, IEEE 1708 Standard for Wearable Cuffless Blood Pressure Measuring Devices provides guidelines for manufacturers to qualify and validate their products. This standard allows healthcare professionals to understand manufacturing practices better when they are purchasing wearable blood pressure devices for their patients. Patients, in turn, can more quickly learn to use new blood pressure home monitoring devices if they switch to a different provider who uses devices made by another manufacturer.
Previously, screening a patient for hearing loss involved specialized equipment and a sound booth, which often meant many people were not screened. However, digital tools now allow hearing pre-screens with simply a mobile phone and a wearable device. Patients with suspected hearing loss are then referred for full evaluations. Because the devices must have interoperability, performance, and specific validation requirements, IEEE P2650 Standard for Enabling Mobile Device Platforms To Be Used As Pre-Screening Audiometric Systems can help create consistency among devices.
2. Standards Facilitate Communication and Interoperability
Using a personal health device to collect your data is simply the first step to improving your healthcare and outcomes. Your providers must be able to access, use, and analyze the data. For this to occur, your devices must connect and communicate with networks, platforms, apps, cloud servers, and other devices. Without standards that facilitate this communication, the process is either difficult or impossible.
Many IEEE Standards help enable this interoperability by allowing disparate technologies to share information across the end-to-end infrastructure.
Local and other area networks are the foundation that begins this process for you to transmit your data and the provider receives the information in real time. Lags and drops can cost minutes — or even seconds — that can be critical in healthcare. The IEEE 802.11 standards family helps enable seamless wireless connectivity among devices.
Many patients with complex medical needs require the monitoring of multiple biometric data, such as weight scale, fitness tracker, blood pressure, and sleep quality. By using the IEEE 11073 family of standards, medical devices such as ventilators and personal health devices such as glucose monitors can be interoperable. A patient can access data from multiple devices at the same time and the provider can monitor all of the data to get a complete view of the patient’s health.
Many devices work together with the patient’s mobile phone to either collect or send the data to the provider. Healthcare systems often collect data for a single patient from multiple devices and then analyze all of the data together for the most accurate view of the patients. For example, a single abnormal number may not be alarming, but multiple different measurements that are not in the normal range may indicate a problem. By using the IEEE 1752.1 IEEE Standard for Open Mobile Health Data—Representation of Metadata, Sleep, and Physical Activity Measures, manufacturers are creating data types that integrate with other device systems so providers have the best view of the patient’s health.
Once the data is transmitted, it’s stored on either a public or private cloud. IEEE 2301 Guide for Cloud Portability and Interoperability Profiles (CPIP) helps cloud vendors, service providers, and users make choices about application interfaces, portability interfaces, management interfaces, interoperability interfaces, file formats, and operation conventions. To enable the portability of data and apps across devices, the choices are divided into multiple logical profiles that address the different cloud roles, such as patient, provider, developer, and administrator. The 2302 IEEE Standard for Intercloud Interoperability and Federation (SIIF) provides guidance for device makers and hospital systems that help with cloud-to-cloud federation and interoperability for both data and devices.
3. Standards Help Keep Personal Health Data Secure
Some patients may be hesitant to use personal devices due to security concerns. The medical device industry prioritizes security and is proactively working to make the devices as secure as possible to help patients feel comfortable using the devices.
To create the foundation for interoperable mobile devices and secure transmission of data, the IEEE P2933 Standard for Clinical Internet of Things (IoT) Data and Device Interoperability with TIPPSS – Trust, Identity, Privacy, Protection, Safety, Security can provide manufacturers the tools to create the interoperability required while also keeping data secure. This standard will allow secure interoperability between wearable clinical devices and healthcare systems, including electronic health records (EHR), electronic medical records (EMR), in-hospital devices, and other clinical IoT devices so that healthcare systems can balance compliance and collaboration.
Some types of devices have specific security concerns. For example, the number of data exchanges and wireless interconnections involved in remote diabetes monitoring creates an increased risk to data safety and patient privacy. Additionally, patients with diabetes use multiple devices, such as blood glucose monitors, continuous glucose monitors, insulin pumps, smart insulin injection pens, and automated insulin dosing systems. With the IEEE 2621 series of standards, manufacturers have a framework to create more consistent and secure diabetes devices.
Advancing Digital Health Devices with Standards
Digital and connected health devices hold the key to helping improve patient outcomes and reduce health disparity. When device manufacturers follow standardized protocols for product reliability, interoperability, and cybersecurity, patients can have better insight into their own health data, more effectively manage their health, and benefit from the ongoing advancements in health monitoring technology.
Learn more about IEEE Standards Association (IEEE SA), a collaborative organization where innovators raise the world’s standards for technology.