Executive Director Continua Health Alliance USA.
As a response to pressures on healthcare, and amidst mounting evidence that health technologies can help solve the healthcare crisis, connected health has experienced a wave of growth that is projected to continue.
There’s no doubt that connected health can improve the quality and efficiency of clinical care, but if it is to become fully integrated into personal health self-management and healthcare delivery, we must commit to user-friendly interoperability standards for devices, services and systems for the individual.
Healthcare systems are stressed by the burden of chronic diseases, which account for a majority of deaths globally and have a significant and growing impact on the overall human burden of disease. Lack of access to nutritious foods, sedentary lifestyle, poor food choices, smoking and the ‘westernisation’ of dietary habits in some nations are contributing to this state of affairs, as well as an unprecedented aging of the global population—which will lead to an even greater demand for healthcare in the future. In the context of the aging healthcare consumer, there is widespread concern about the ability to contain costs in nations of the Asia Pacific region, particularly those nations experiencing the most rapid population ageing.
Simultaneously, connected health technologies have become available to make healthcare more efficient, effective and accessible, with potential to deliver cost savings over the long term. Perhaps the most predominant examples of connected health in the market today are remote home monitoring programmes implemented by hospitals. These programmes have demonstrated success for managing chronic conditions such as diabetes, asthma/COPD, and congestive heart failure.
At the other end of the spectrum, the consumer mass market is being flooded with mobile health apps and personal health devices that enable consumers to manage their health independently---and they’re responding. Global revenue for consumer medical devices was predicted to reach US$8.2 billion by the end of 2013, according to HIS, with the Asia Pacific region representing a substantial area of growth.
Connecting the market
The vision for connected health is one in which provider-implemented programmes can easily scale to thousands or even millions of patients with seamless data relay between a variety of devices and systems. Furthermore, in order for healthcare systems to fully enable and participate in consumer-centric healthcare delivery, mass market devices and services will need to achieve user-friendly connectivity with hospital EHR systems and a vast array of personal devices and services which consumers may choose to connect in pursuit of their individual health goals. In addition, individuals are beginning to connect their health information into social networking either for comparisons to friends or to seek out specific medical knowledge. Attaining this vision will necessitate investment in a new kind of healthcare infrastructure: interoperability standards.
Interoperability refers to mutual connectivity between devices, systems and services. Unfortunately, in today’s market vendors can legitimately claim interoperability when their products actually require a great deal of back-end integration that defies the simplicity conveyed in the concept of interoperability. Furthermore, integration can create delays and cost increases, or simply discourage the integration of new products within a network of connected devices and cause further problems when upgrades occur. Authentic interoperability requires minimal implementation and focuses on user-friendliness, a critical characteristic of any technology aiming at widespread use, with a provision for backward compatibility. The solution is to adopt interoperability standards in connected health.
Continua Health Alliance publishes Design Guidelines for plug-and-play (simple, user friendly), end-to-end connectivity of personal connected health devices, systems and services. ‘End-to-end’ refers to connectivity from the device to the hub and on to the electronic record system; and, between the consumer and the healthcare system that includes doctors, caregivers, family and other people in the consumer’s social circle. In December 2013, these Design Guidelines were recognised as a global standard by the United Nations’ International Telecommunication Union (ITU), one of three global standards bodies.
When user-friendly interoperability is achieved, it shifts the value from device integration to data aggregation at both individual and population levels, enabling the capture, storage and analysis of health data across a 1-user, novel network created by a single consumer seeking a custom health management solution as well as access to billions of data points to drive massive public health programming or targeted responses to meaningful sub-populations.
The concept of interoperability standards as a necessary healthcare infrastructure can be likened to the brick-and-mortar infrastructure of a nation’s roads and highways, which function as a fundamental support for commerce as well as the free exchange of ideas that leads to innovation. In this context, it can be said that the connected health market of today is focused on building the cars (devices) rather than the roads. Interoperability standards, like a system of roads, are foundational to seamless health data relay and innovation. There’s simply no better way to achieve scale in data access and exchange. Furthermore, investing in interoperability standards will yield better returns on healthcare technology investment, since it facilitates the ability to repurpose interoperable devices and add different device types for clinical programme expansion.
If an interoperable ecosystem is achieved, healthcare will become more effective in three major areas: population health management, drug development and most importantly, personalised healthcare.
Ubiquitous adoption of interoperability standards is the key, which will generate new population insights to support enhanced preventive care and enable improved responsiveness to developing trends. Innovation will also result, with the flow of data on a large-scale between diverse sources and geographies spurring novel collaborations.
In drug development, interoperable big data will set off a stream of beneficial impacts: more accurate data collection methods which will in turn facilitate faster, smaller, or deeper studies, with potential for decreased cost. One area of clinical research that seems particularly likely to benefit drug manufacturers is improved measures for adherence to therapies during trials, which inhibits accurate measures of effectiveness in current drug trials.
These Startup Values will lead to beliefs that are common among entrepreneurs but often foreign within larger organisations. These beliefs will lead to different kinds of actions that are typical with HIT.
If cost decreases can be achieved in technology-enabled trials, trial sponsors may choose to undertake direct studies that lead to the recognition of sub-populations for whom there are clinically significant difference in drug response, leading to the availability of more targeted therapies and the introduction of new clinical diagnostics for personalised medicine. Post-marketing studies or monitoring of individual patients taking a commercially available product may also yield beneficial information about adherence and drug response.
Government investment and interest in interoperability and connected health are thankfully increasing. As the world’s predominant healthcare payers, governments have a substantial role to play in helping to realise the vision for interoperable, consumer-centric healthcare delivery.
Over the past few years, governments—notably in smaller nations—have made several important advancements in connected health. Japan, already a leader in mobile health, announced that it will create one of the world’s most advanced federal IT systems, to include health and wellness. In the US, the FDA formally recognised 25 standards for medical device interoperability that included applications of risk management for IT networks; health informatics related to point-of-care and personal device communication; and system security for industrial communication networks. A senior policy advisor to the initiative said in a post on the FDA Voice blog:
"As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records, there is a growing expectation that they will be interoperable--and that the data they transmit will be secure. Making sure devices are interoperable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can 'plug and play.'"
Additionally, the Policy Committee of the US Office of the National Coordinator for Health Information Technology (ONC) announced that it’s considering including patient-generated health data from remote monitoring devices as a potential requirement of US Meaningful Use regulations, which provide incentives to healthcare providers for specific achievements in the use of Electronic Health Records (EHR) systems used to provide care for patients covered by the government funded Medicare and Medicaid programs.
Denmark achieved a global milestone for interoperability in 2012, when it adopted Continua Health Alliance’s interoperability Design Guidelines across its healthcare system in 2012, becoming the first nation in the world to do so. Following guidance from the Industry Working Group of the UK’s 3millionlives telehealth campaign, Three Clinical Commissioning groups of the UK’s National Health Service also adopted Continua’s Guidelines in issuing their tender for the programme. Singapore’s Health Ministry is also looking toward interoperability standards, and will roll out the guidelines as part of its population-wide mhealth project, which initially aims to manage cardiovascular and diabetic risk.
Finally, there is new interest in adopting interoperability guidelines for public safety and disaster recovery, where coordination of services (or lack thereof) can have life and death consequences.
Interest and investment in personal connected health is on the rise; there are also signs of increased demand for and awareness of interoperability as a critical means of facilitating effective healthcare and sound healthcare technology investment over the long term. But achieving interoperability, and thus enabling attainment of the vision for connected health, will depend upon implementation of interoperability standards that set a high bar for simple, user friendly connectivity from consumer to provider.
Chuck Parker leads the many workgroups and day-to-day operations of the Alliance. Chuck has over 20 years of experience in healthcare technology, policy, and the strategic design of evaluation and measurement strategies. He has led national programs for practice transformation and has served on national committees for assessing adoption requirements.