Always being connected
Gone are the days of reading a book on the way to work. Instead, we’re glued to our smartphones, because we can use them to answer emails, make purchases and reservations, pay bills, read the news, or “chat” with friends on diverse apps. It is all possible thanks to good Internet connections, tablets, iPads, smartphones and other portable smart devices. Technology has given us the freedom to get many things done while on the move. As well as constantly monitoring and recording what we do, we also share it with friends or colleagues on different social media platforms.
It comes as no surprise then, that the health and fitness industries are using this technology in very diverse wearable smart devices (WSDs), which can be worn on or near the body to monitor everything from sleep patterns, heart rate and the amount of steps we take, to glucose levels or body temperature.
Booming wearable healthcare
The value of the wearable electronic technology market will rise from USD 20 billion in 2015 to USD 70 billion by 2025, according to research company IDTechEx. This is hardly surprising given that some of the largest technology, medical and sports companies are heavily invested in developing the industry. According to this research, healthcare is the biggest sector, comprising medical, fitness and well-being.
As millions of people use wearables every day to check their health and fitness, they will need to trust that this technology is safe, reliable and compatible with other technologies, and functions as expected.
Medical wearable devices and their parts
Medical wearables come in different shapes and sizes. On the whole, they are getting smaller, thanks to the evolution of nanotechnology, which involves manipulating materials on an atomic or a molecular scale to build microscopic devices. They are also getting smarter as components such as microchips, biosensors and very small-scale batteries allow them to connect to external smart devices, and transmit the information they gather.
Printed electronics or the printing of circuits on rigid or flexible substrates, is often merged with 3D printing for use in different medical applications, such as for the above-mentioned patches, glove-like heart monitoring devices or cochlear implants.
A number of IEC Technical Committees (TCs) and Subcommittees (SCs) develop International Standards for the components contained in medical wearables. IEC TC 62 creates Standards for electrical equipment in medical practice. Much of this electronic technology relies on sensors.
IEC TC 47: Semiconductor devices and IEC SC 47F: Microelectromechanical systems, enable the development of reliable and efficient sensors and MEMS. The work of IEC TC 113: Nanotechnology for electrotechnical products and systems, comprises terminology, measurement and characterization and performance assessment of substances for certain coatings on implanted devices.
Printed electronics Standards are developed by IEC TC 119, which covers printed electronics parts, their terminology, materials, processes, equipment, products and health/safety/environment aspects.
These devices are powered by batteries. IEC TC 21: Secondary cells and batteries, works on safety installation principles, performance, battery system aspects, dimensions and labelling.
Mobile medicine benefits many people
Portable medical devices bring great benefits to patients and how healthcare is being managed. They allow for real-time monitoring of patients 24 hours a day, for example continuous glucose monitors. Patients also receive alerts for lows and highs, and these devices are also discreet. They reduce doctor visits and give patients more time and freedom to live normal lives despite their conditions.
Patients in remote areas, disabled or aged people who may not be as mobile using such devices, can receive healthcare from a distance. Data gathered by the monitors is conveyed to doctors or health centres from smart devices, using different telecommunications technology.
As many countries face rapidly aging populations and significantly increased healthcare costs, active assisted living (AAL) offers solutions to extend independent living through the development and smart deployment of consumer electronics, connected and wearable medical and health-related devices.
IEC standardization work will prove crucial for the development of this sector, which will provide improved health and quality of life for millions of people, as well as major industrial and economic benefits.
The IEC established the Systems Committee on Active Assisted Living (SyC AAL), tasked with fostering standardization to enable usability and accessibility of AAL systems and services, and importantly, cross-vendor interoperability of the systems, services, products and components. It will also address systems-level aspects such as safety, security, including cybersecurity and privacy.
Also, IEC TC 100: Audio, video and multimedia systems and equipment, has created Technical Area (TA) 16 to address AAL aspects such as ‘accessibility, usability and specific user interfaces related to audio, video and multimedia systems and equipment within the scope of TC 100'.
How to trust the technology with your life
The monitoring and treatment of many medical conditions requires accurate, timely readings. Medical wearable devices monitor aspects of the heart (blood pressure and electrical and muscular function), read glucose levels in diabetics, and track the movement of elderly people. Medication doses are based on these measurements, and in the case of monitoring movement, reaching a person who has fallen over as quickly as possible could mean the difference between life and death.
People put their trust in these devices and expect them to function safely and reliably. The technology is evolving at a pace and becoming smaller, smarter and as a result delivering enhanced performance and functions.
The electronics which make these devices work are comprised of many components, such as, sensors, connectors, resistors, capacitors, semiconductors, diodes, light-emitting diodes (LEDs), microelectromechanical systems (MEMS) and nanoelectromechanical systems (NEMS), to name several.
Electronic component manufacturers and suppliers can use IECQ, the IEC Quality Assessment System for Electronic Components, to ensure that their products are safe, reliable and meet the strictest quality requirements.
Concerning the environment, IECQ developed a Scheme that has been running for over a decade, to ensure that products comply with the hazardous substances regulations: IECQ Hazardous Substances Process Management (IECQ HSPM). Products certified by the Scheme demonstrate that electrical and electronic components and assemblies meet hazardous substance-free local, national or international requirements such as the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) European Union Directive.
Protecting medical data
When we think of biometrics, often the first thing that pops to mind is having a fingerprint or iris scan for identification purposes, for example when clearing immigration in certain countries. However, medical biometrics or personal medical data, such as digital images and biorhythm recordings from ECGs and CTs have existed for decades. The digitization of these, combined with the new wearable technology and its real-time measurement capabilities, allows medical personnel to exchange this information with colleagues and develop data sets for solving medical problems and improving healthcare services.
Biometric data other than fingerprints and iris scans may also one day be used for security identification purposes.
Data has little value if it cannot be transmitted and received between medical professionals or patients and doctors. ISO/IEC Joint Technical Committee (JTC) 1: Information technology, prepares International Standards which cover data interchange formats and technical interfaces among others.
More personal information is being gathered by medical wearables and transmitted over the Internet to healthcare facilities, which use computerized management systems to store this information electronically. Patient files are gradually being converted from paper to what is known as electronic health records by hospitals, medical centres and doctor’s surgeries. Results from many of today’s medical scanning devices are saved on computers. Patients walk away with a compact disc showing still or moving scans, which can be easily accessed, used and shared between medical professionals and patients.
This type of technology has enabled the development of remote patient monitoring solutions, which are very useful for aged or disabled people with less mobility, or those in isolated locations.
We regularly hear about cybersecurity breaches, which also affect the healthcare industry. Based on a list compiled by the US Department of Health and Human Services, by March this year, 3,5 million medical records had already been compromised. Medical records in the US can be even more valuable than credit card theft, because they contain details such as social security numbers and addresses, which can then be used by fraudsters. The use of standards satisfies national and/or international security and privacy requirements which are increasingly important.
IEC actively works towards stopping cyberattacks and maintaining data privacy and security in a number of areas including medical. IEC TC 62 and its Subcommittees (SCs) develop International Standards that cover medical device software used in healthcare. There scope also includes “data security, data integrity and data privacy”.
ISO/IEC JTC 1 produces International Standards for the security of information technology. Additionally, the IEC Advisory Committee on information security and data privacy (ACSEC) deals with information security and data privacy matters, coordinating activities related to these topics and providing any TCs with guidance for the implementation of information security and data privacy.