Continua Releases Connected Device Guidelines
We talked with Chuck Parker, executive director for the Continua Health Alliance, an organization for health care device makers. The organization recently released a new set of guidelines for personal connected health care devices.
The focus of all their guidelines is on three areas; disease management, especially for monitoring in homes and at rehabilitation facilities, independent living, and health and wellness enhancements. Typical devices include weighing scales, thermometers, blood pressure monitoring, etc. for all types of people and medical conditions.
The latest release includes: the addition of the Wide Area Network (WAN) interface, which takes data from an aggregation or hub device, such as a PC, mobile phone or health appliance, and sends it on through a standardized model for remote monitoring servers or electronic health records. Support for two new Personal Area Network (PAN) and Sensor-LAN device types: Peak Flow Meters and Adherence Monitors for use in medication monitoring. Updates and enhancements to the ISO/IEEE Base Framework Specification which defines a common transmission protocol of Continua device data regardless of the device or application. The addition of ZigBee support into the Sensor-Local Area Network (Sensor-LAN) interface, which was selected for its efficiency in working with multiple sensors in the home. And email support to the Health Record Network (HRN) interface, which is the interface between a remote monitoring server and an electronic health record.
The guidelines define data flow for a store and forward process. This format only holds data locally for transmissions and retrys. They deemed it better to lose some data than to have to consider the issues of data retention. The security provisions in Bluetooth and Zigbee are considered sufficient for this type of data transfer. Data is transferred on a low-power, low duty cycle burst mode to save power and bandwidth resources.
Health data profiles are managed with secure servers and all data is passed through the systems in encrypted form. The guidelines expect these factors to suffice for US and EU health data security requirements. Data formats are based on the HL7 message stream format and result in clinical care documents at the practitioner’s terminal.
The guidelines include requirements for descriptions of the device’s functions and user interfaces must have provisions for physically impaired uses; large button(s), high visibility and simple icons. The organization does not want to be another standards body, so they are trying as much as possible to leverage other regulatory organizations and standards bodies to create the actual requirements for compliance issues and confirmation.
The Continua Alliance is working to address the needs of people all around the world. In the developed countries, there is 1 hospital bed for every 100 people. In emerging economies like India and China, the ration is 1 bed per 50,000 people. By creating new health care delivery devices and technologies, they hope to deliver and help to manage peoples’ health care where they are and at costs they can afford.
The Continua Alliance has workgroups looking at issues like reimbursement, work flows, and many others to try to address the growing need for alternatives to the established healthcare delivery system. The rapid aging of the world’s population calls for new ways to manage and accommodate the rising and changing needs of the world’s population.
