Medical Devices Come HomeMedical Devices Come Home

As the population ages and the number of people requiring medical treatment rapidly increases, the U.S. government is looking for ways to improve the healthcare system. Patient-centered in-home care for individuals with diabetes, heart disease, and other chronic conditions is ideal for most patients, but it can be expensive. Now, technology is advancing to meet the challenge with medical devices in the home that quickly and easily link to electronic health provider records. 

There are numerous challenges involved in developing connected medical devices and other applications. The in-home network connection must be simple and provide reliable data. Once the data are collected, they must be secured according to prevailing industry standards. It is critical not only to collect the data but to seamlessly provide that informatio though common practices between nursing services, doctors, hospitals, pharmacies, insurance companies, and other care providers. With thousands of medical devices manufactured by hundreds of companies, clear industry guidelines are essential to the advancement of telemedicine.

As opposed to proprietary solutions controlled by a single provider, open standards–based solutions open the door for an interoperable ecosystem of medical devices and electronic health records. Open standards and interoperability have the potential to make connected health devices a cost-effective and viable reality.

The Need for Telemedicine
While politicians debate the future of our healthcare system, manufacturers can use cutting-edge information technology (IT) to improve efficiency and reduce costs in the short term.

According to the World Health Organization, there are 1 billion overweight adults, 860 million chronic disease patients, and 600 million people over age 60 worldwide. Chronic disease management eats up 75–85% of total healthcare spending. In the United States, an aging society and the possible adoption of universal healthcare coverage will continue to rapidly increase the financial burden on the healthcare system and ultimately, taxpayers.

To put the estimated financial burden in perspective—if 10 million people required just one annual checkup, an additional 5000–10,000 healthcare professionals would be needed to maintain the current standard of care in the United States. Not many of these professionals are unemployed today, and training new healthcare professionals

takes many years. In the short term, the additional man-hours can be obtained via efficiency improvement.
The number of individuals in the healthcare system isn’t the only rising statistic. The amount of required patient care is also increasing, which follows the trend of an aging population (see Figure 1). The aging population demands the most care for chronic conditions and therefore potentially requires the most expensive care. The use of telemedicine—in–home care augmented by smart devices—will reduce costs if implemented correctly. In addition to treating chronic conditions, telemedicine aims to improve the quality of preventative in–home care (see the sidebar, “Effect on Preventative Care”).

Historically, the medical field has been slow to embrace new technology. A $50 car repair leads to various database updates that are available to other industries such as maintenance technicians and car buyers. However, the results of a $5000 diagnostic test or a major operation are often stored in a paper file or in a database typically available to only one healthcare provider. The lack of shared medical information can lead to misdiagnosis, improper treatment, and redundant tests, causing healthcare costs to rise, while quality falls.

Recent calls for reform and government initiatives are starting to accelerate the adoption of electronic medical records and other new technologies. As more people enter the healthcare system and the need for efficiency and cost savings increases, resources become limited. More individuals face chronic conditions like diabetes, heart disease, obesity, asthma, and other chronic cardiopulmonary diseases.

The U.S. Department of Veterans Affairs performed an extensive study on the benefits and costs of in-home telemedicine on various conditions.¹ As Table I shows, using telemedicine decreases cost. The same study also shows quality improvements such as a 25% reduction in the number of bed days of care, a 19% reduction in the number of hospital admissions, and a mean satisfaction rating of 86% after enrollment in the program.

Monitoring and treating chronic conditions in the home is the area where IT networks and medical device design can have the biggest effect on efficiency in the healthcare industry. Home care increases the quality of life for patients and isn’t as expensive as residential or acute care (see Figure 2). The goal is clear—better monitoring for more people with a connected healthcare system. How can this goal be reached?

Interoperability for In-Home Devices
Patient monitoring devices are not always costly. Many critical devices for chronic conditions are sold by major retailers or online. For example, blood pressure cuffs, pulse oximeters, and glucose meters are available for less than the cost of a single doctor’s visit. Other possible requirements for chronic care monitoring can include a weight scale, fitness equipment, a pedometer, a pressure switch on a bed that monitors sleep, or motion sensors to monitor activity in a house. These products provide important information about a patient’s health. However, there are challenges involved in integrating the devices into a cost-effective, cohesive system.

The first issue is device protocols, which consist of more than bits and bytes. A comprehensive protocol that attaches a medical device to a healthcare system must reflect the functions of the device itself. The protocol should include an object model of the device, the units of measure, and other intricate details.

Efforts to standardize device protocols have been under way for years, published and controlled by a family of ISO, IEEE, and the European Committee for Standardization joint standards addressing interoperability. The ISO/IEEE 11073 standard family defines the parts of a system, ways to exchange and evaluate vital signs data between different medical devices, and a way to remotely control the devices. The specifications define the relationship between a device and the gateways between the device and the larger healthcare system.

Because many health monitoring programs require multiple devices, an in-home gateway is essential. The gateway could be a set-top box, home security system, purpose-built hub, purpose-built terminal, cell phone, or a personal computer. Regardless of the type of gateway that is set up, ease of use is the most important factor in improving the quality of in-home care. The target audience for in-home telemedicine care is not always technologically savvy, so the communications tool must be plug-and-play and intuitive in operation. Users should not be expected to reboot the system, set daylight saving time, or install virus updates, and thus 100% remote maintenance is required.

In-home medical devices require more than simple adherence to standards; approval is required. New devices, including those that take a measurement of vital signs such as heart rate or respiration, require a full 510(k) listing through FDA. Other devices, such as computer gateways between the measurement and the healthcare application, might only need the 510(k) approval since they are similar to previously approved devices.

Advancing Open Standards
To promote widespread adoption, medical device specifications must be demonstrated and proven. Two major industry efforts are seeking to advance the interoperability of in-home devices.  

Continua Health Alliance is a nonprofit, open-industry coalition of more than 220 leading healthcare and technology organizations around the world. The group’s mission is to establish an ecosystem of interoperable personal connected health solutions designed to empower individuals and provide personalized health and wellness management.

Members contribute to and vote on Continua Design Guidelines and meet at Continua-sponsored events to verify device compatibility. The guidelines specify how to use existing industry standards to build interoperable personal healthcare products (see Figure 3).

Continua members pay an annual fee and acquiring the relevant IEEE or ISO specifications is included. For the membership fee, Continua provides members with software libraries, certification testing, and marketing benefits.
There are two major online personal health record applications today—Microsoft HealthVault and Google Health. These applications target consumers and allow them to create an electronic record that they can control and share, as they see fit, with healthcare providers. Microsoft has been demonstrating interoperability with Continua devices since June 2009.

Network Considerations
The benefits of telemedicine are only realized as part of an effective, widespread system. There are a number of network constraints, including security and data ownership. 

Regulations published as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) include strong privacy guidelines. Health insurance plans, most healthcare providers, and healthcare clearinghouses must obey HIPAA rules, which go beyond security and encrypted data. Patient have the undisputed right to control who sees their medical information, and the patient can limit how the information is used.

To achieve the appropriate level of control, medical device developers typically keep medical device data separate from patient identity information until they meet on a formal electronic medical record (EMR). EMRs are well defined and regulated, and they are typically stored by a healthcare provider or clearinghouse (i.e., HealthVault or Google Health). Access to EMRs is based on a set of rules that present specific data according to the role of the healthcare professional and insurance plans, for example.

Connecting to the network might not always be easy. Phone lines can be pulled, Internet connections can vanish, and cable TV preferences change. The most secure way to get into the network cloud today is by networking via the wireless wide area network or the cell phone 3G networks. The bulk data requirement and number of connections per day is not enough for most applications, but cell phone carriers may offer favorable rate plans for expansion.

Keep the Data Flowing
Once the device data are transferred to an EMR, they can be shared according to a set of rules determined by the patient and healthcare provider. Sharing data quickly and appropriately is a hot topic in the healthcare community. To use healthcare professionals’ time effectively, most of the reporting happens by exception. For example, a system might alert the doctor if the patient’s blood pressure or weight suddenly changes. Although most of the logic associated with exception reporting is done in the  network cloud, the business rules in the environment might affect the device design and approval. Specifically, if the device and its associated business rules diagnose an issue and decide to involve a professional, the device is subject to more rigorous approval standards.

The primary enterprise concern for device manufacturers is to support remote maintenance of the device and the gateway (see Figure 4). Several events can require maintenance on the gateway or device such as new tests, new measurement devices, recalling old devices, or patching software vulnerabilities. Because one underlying objective of connected health systems is to reduce the number of visits to the home, remote maintenance of the device is critical.

Conclusion
Connected health systems are poised to receive widespread attention and adoption in the next decade, driven primarily by cost reduction. Open standards offered by organizations like Continua are driving continued innovation and hundreds of new in-home medical devices are on the horizon. Both healthcare providers and patients will benefit as products currently used only in an ambulance, emergency room, or doctor’s office can be cost-engineered to fit into a home health scenario.

Other devices now have the capability to develop connected interfaces and provide useful data to healthcare providers, such as video games with aerobic health components. Advanced networking options such as the 3G cellular networks and standards for EMR are also helping to drive costs down and improve quality. Technological advances are allowing in-home healthcare devices to be passive and wireless, which is less invasive for patients. As costs continue to drop and infrastructure expands, more people, with or without government stimulus, may start to incorporate connected health into their lifestyle. Clearly, telemedicine is coming of age. 
 

Reference
1. A Darkins et al., “Care Coordination/Home Telehealth,” (Department of Veterans Affairs, Office of Care Coordination Services, Washington, D.C.) December 2008.

Haritha Treadway is project manager at Eurotech Inc. (Columbia, Maryland).