eHealth, mHealth, EHR, EMR, HIT and Medical Device Interoperability
Announcements:
September 2012 - UL and AAMI announce collaboration on medical device interoperability standards. Click here to view the press release.
eHealth:
eHealth is a term (e is an abbreviation for electronic) that defines the use of electronic information, process, tools and environment in healthcare. eHealth has several definitions. The WHO (the World Health Organization) defines eHealth as: "the use of information and communication technologies (ICT) for health."[1]. Several different applications run under this definition and as such, they are referred to under several different names.
Medical Device Interoperable Systems:
To facilitate and improve current patient safety and reduce the chance of accidents, medical devices need to be able to both communicate with each other and function effectively and safely in an interoperable environment through specialized interfaces. Some of this interoperability has been achieved through third party "middleware", allowing multiple devices to be used on a single patient in an environment without interfering with each other and in such a way that they actually complement and react to the function of each other. In other cases, interoperability has been achieved through a closed-loop proprietary system. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry is therefore demanding standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe.
Click the Image to learn more about Interoperability:
Electronic Health Records (EHR) Electronic Medical Records (EMR):
EHRs and EMRs are the collection of patient data that are used to support the patient file, physician diagnosis and treatment and insurance reimbursement. Having secure yet easy access to patient data can provide many efficiencies and advantages to the healthcare system. Due to the sensitive nature of patient privacy, the data needs to be secure, private and free of errors.
As with interoperable medical devices, EHR's and EMR's, when part of a complex interoperable ecosystem, need to operate in a safe way, avoiding the risk of errors in data allocation or appropriate filing and recording.
mHealth (Mobile Health):
Mobile health is the health information technology sector that enables eHealth services and use by means of mobile devices such as PAD (personal access devices), smart phones and others. mHealth uses wireless technology for the transfer of information.
Mobile applications related to the function of medical devices in an interoperable system are software programs that can reside on mobile devices. The FDA defines mobile applications as "software programs that run on smartphones and other mobile communications devices". [2]
Market Drivers for eHealth:
- People, insurance companies and governments are demanding an improvement in the quality of healthcare and available information.
- The cost of healthcare and anticipated increases in healthcare spending due to the aging population is creating a demand for better solutions.
- New technologies, communication and connectivity have stimulated the medical device and healthcare industry.
UL's role in eHealth:
UL‘s mission is to promote safe living and working environments for people by the application of Safety Science and Hazard-Based Safety Engineering.
UL's primary focus is the safety of interoperability in eHealth and telemedicine and related areas of application. It is UL's intention to lead/support the development of interoperability standards in conjunction with other standards development organizations (SDO) and regulatory bodies for the interoperability testing and verification of eHealth devices (both medical devices and eHealth products).
Contact:
Please contact us if you are interested in discussing your views and needs in this new sector. Email Medical.Inquiry@ul.com
Additional Resources:
- Connecting Mobile Medical Devices (registration required)
- Link to FDA "Mobile Medical Applications" (draft) Guidance
- Link to UL Home Healthcare equipment page
- Link to COCIR documents on eHealth and Telemedicine COCIR is the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
- Link to on-demand eLearning module "Bringing Wireless RF Technology to Medical Devices"
References:
[1]http://www.who.int/topics/ehealth/en/ May 29, 2012
[2] http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ucm255978.htm



