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1 MOBILE DEVICES 2013 Fall MED_INF_405-DL_SEC55 Interoperability and Health Information Exchange for Mobile Health Monitoring Devices Team Project Group 4 November 24, 2013 Team Project Group 4: Eric Chavez Kenneth Mahung David West 2 MOBILE DEVICES Introduction Group Project Team 4 chose to do a literature review on mobile health device standards. The term “mobile devices” includes personal health care devices that directly measure one or more physiological parameters by remote action often outside of a health care setting. Examples of devices included in this scope are glucometers, weight scales, peak flow meters, and cardiac rhythm monitors, though other devices could qualify by this definition. Examples of devices that would not be included in this scope include diary recording devices, medication compliance devices educational devices. The literature review examines the standards that apply to transmitting data to remote health care settings by both wireless and wired configurations. Specific questions that the literature review seeks to address will include: what are the breadth and type of mobile medical devices and what data are being exchanged? What are the current mobile medical device interoperability standards and what are the organizations developing them? What is the status of mobile device interoperability standards adoption? What are the security concerns for mobile devices? What are future directions and concerns for mobile health device standards? Mobile medical devices are becoming more and more common in healthcare. The ability to passively acquire and transmit data has great potential appeal for patients. They would not have to transcribe or otherwise take steps to transmit data. There is great potential appeal for health care providers also. They would not have to worry about authenticity or latency in the data. In order to make these devices more useful and to improve patient safety, it is necessary for these devices to communicate with applications that can organize and present the data in a useful manner to clinicians, and in addition have the data integrated and trended with like data from other sources. Connecting devices developed and manufactured by different organizations can be a huge task. Interoperability standards are necessary to build the interfaces that can link these devices to larger information systems. According to Moorman (2010), “the ultimate goal of interoperability is a seamless flow of information between many disparate devices over a network to and from the intended recipients. The key word is disparate such that different vendors can communicate over different networks to different recipients.” Once mobile devices are linked to larger systems, two-way communication can allow data collected from the mobile devices to be stored in an electronic health record and information from the hospital information system can be used to control the device. The exchange of data can be used to influence the function of other mobile devices using decision support systems. Central hospital management systems can control the functions of the mobile devices, recognize when they are malfunctioning, and remotely repair and configure them. Even though mobile devices are more prevalent in healthcare and interoperability standards are the foundation for making these devices more functional and safe, traditional standards development organizations and agencies such as Health Level Seven (HL7), the Food and Drug Administration (FDA), the Federal Communication Commission (FCC), and the Federal Trade Commission (FTC) are just starting to recognize the need for oversight and greater interoperability (Brandt, 2012). Research Hypothesis The research hypothesis is that mobile medical device standards for interoperability are neither wellestablished nor adopted. There are few standards development organizations (SDO) that are focusing on mobile medical devices. When mobile medical device standards for interoperability do exist, they are often overlooked by those organizations that are currently producing and using mobile medical devices. This may be because the rate of introduction of new mobile devices is very great and because there is relatively little government oversight and regulation of mobile medical devices. Also there may be some debate about what actually qualifies as a mobile medical device. Lack of mobile medical device interoperability standards may create safety issues when these devices are used by patients both in remote settings and in medical facility settings. Methods A literature review was conducted using multiple sources including peer-reviewed journal articles, technical white papers, technology web sites, and news articles. 3 MOBILE DEVICES Results Definition of Mobile Health Devices and Data As we approached this topic, we thought it important to provide background as to what constitutes mobile health devices and what types of data are typically shared in an interoperable setting. To lay this foundation, it is worth noting that the Office of the National Coordinator of Health Information Technology (ONC) contracted with The Health Information Technology Standards Panel (HITSP) headed by John Halamka MD to “advance the widespread interoperability and adoption of electronic health records” (Blumenthal, 2010). The HITSP is a cooperative partnership between public and private sectors. The Panel was formed for the purpose of harmonizing and integrating standards that will meet clinical and business needs for sharing information among organizations and systems (HITSP website). The HITSP had several working groups highlighted by this diagram: Figure 1 HITSP Workgroups The Consumer Perspective Technical Committee addressed mobile medical devices in a document called the “HITSP Remote Monitoring Interoperability Specification” which was subsequently released on December 18, 2008 (Consumer Perspective Technical Committee, 2008). Within it are contained the types of devices being focused on and a set of specifications that help to describe the types of data which are currently expected to be exchanged from these devices. The devices are categorized as follows: Blood Glucose Meter Blood Pressure Monitor Brain Activity Cholesterol Esophageal pH Heart Rate Heart Rhythm Implantable Cardioverter Defibrillator (ICD) Monitoring Lung Function Oxygen Saturation (Pulse Oximeter) Respiration Rhythm 4 MOBILE DEVICES Temperature (Thermometer) Weight (Weighing Scale) Data elements described for each of these devices contain not only the physiological parameters (e.g. blood glucose, weight, etc.) but also many contextual parameters such as tester id, device id, date and time, and sample location. The list above is not intended to be in any way limiting to future activities, but simply represents the scope of remote home monitoring devices commercially available at the time of the report. What they all share is the ability to digitally record direct measurements of physiology and/or biological condition. Personal devices like smart phones are viewed as intermediary devices in this context as they are one step removed from the sensor itself. However, that gap is diminishing with new types of sensory devices that may be attached to an iPhone. Even with just its light feature, an iPhone can easily measure a pulse. An iPhone is not, however, equipped by itself to record, store, and transmit this data. For now it is not among the devices that fit in these categories, but the lines will likely get greyer and greyer. One might imagine when medical devices start to become more integrated into more consumer goods such as clothing, automobile seats or furniture. Mobile Health Device Interoperability Standards and Standards Development Organizations A review of the literature of mobile medical devices shows that there are relatively few organizations that are focused on the development and dissemination of interoperability standards for mobile medical devices. Some of these organizations are very well-known standards development organizations such as the Institute of Electrical and Electronics Engineers (IEEE), the International Organization for Standardization (ISO), the European Committee for Standardization (CEN), the National Institute of Standards and Technology (NIST). Some are well-known health information technology (HIT) standards organizations such as Health Level Seven (HL7) and Digital Imaging and Communications in Medicine (DICOM). The most commonly referenced organizations devoted to mobile medical device interoperability standards and those which were listed as the four most important organizations according to Moorman in her 2010 article are: the Continua Health Alliance, Integrating the Healthcare Enterprise (IHE), American Society for Testing and Materials-Integrating the Clinical Environment (ASTM-ICE), and the Health Information Technology Standards Panel (Moorman, 2010). See Table 1 for a summary. CEN ISO/IEEE 11073: The most commonly referenced set of standards in the literature review of mobile medical device interoperability standards is the CEN ISO/IEEE 11073 Health Informatics – Medical/Health Device Communication family of standards. A good review of this family of standards can be found on Wikipedia (ISO/IEEE 11073 at http://www.wikipedia.org/wiki/ISO/IEEE_11073). The standards provide for automatic data capture from devices including physiologic data from monitoring sensors on patient and data about the operational status of the device itself. The standards allow for two-way communication between the mobile devices and larger information systems. This family of standards is so ubiquitous in the literature about mobile medical devices because these standards provide the solution for device connection through all layers of the Open Systems Interconnection (OSI) model. In particular the ISO/IEEE 11073 Personal Health Data standards are targeted for small mobile devices such as weighing scales, pulse oximeters, blood glucose monitors, blood pressure monitors, peak flow meters, thermometers, medications monitors, and others. The ISO/IEEE 11073 standards allow for a high degree of interoperability. Once connected, mobile devices send information which informs the larger system about the mobile device and how to communicate with it. The standards allow for two-way data transmission simultaneously among several devices. All data is time correlated and can be retrieved, displayed, and stored automatically and nearly instantaneously. Systems built with these standards are capable of capturing data at the point-of-care and transforming the data so that it can be retrieved, processed, and archived by a variety of different applications. The standards provide syntactic interoperability through defined message structures and semantic interoperability through a core nomenclature (Brandt, 2012). Galarraga (2007) describes how the 11073 standards might be used in a home health monitoring scenario. Several small devices with sensors to monitor the patient’s physiologic parameters will be integrated and connected via a Body Area Network (BAN) or Personal Area Network (PAN). The BAN or PAN is then connected to an integrated compute engine through a Local Area Network (LAN). The compute engine is connected with a telemedicine server. The telemedicine server is then connected to the larger hospital information system or EHR. The most critical need for interoperability standards is in homogenizing the interface between the disparate mobile medical devices and the compute engine (Galarraga, 2007). This is the role of the ISO/IEEE 11073 family of standards. Different standards within the family allow for device connection to a network via a wired or wireless 5 MOBILE DEVICES medium, inter-device communication, and communication between the devices and the EHR, all while maintaining syntactic and semantic interoperability. Continua Health Alliance: The Continua Health Alliance is not a standards development organization. It is a group of more than 200 companies from the healthcare, communications, and technology industries (Continue Health Alliance website). It produces guidelines for mobile medical devices based on current interoperability standards and certifies mobile devices to be interoperable. Devices certified by Continua allow nearly plug-and-play compatibility. The organization aims to establish systems of interoperable devices for chronic disease management and telehealth. Continua-certified products rely on the ISO/IEEE 11073 family of standards and protocols for data exchange in the upper layers of the OSI model and on Bluetooth and USB standards for data transmission in the lower layers. Integrating the Healthcare Enterprise: Integrating the Healthcare Enterprise (IHE) is an international organization based in the U.S. It is primarily concerned with initiatives which help to improve the way computer systems share information by identifying interoperability standards and developing technical guidelines that manufacturers can use when developing new products (IHE website). IHE divides itself into several specialty domains. The Patient Care Device (PCD) domain is concerned with defining standards for interfaces between pointof-care medical devices such as infusion pumps, ventilators, implantable cardiac devices, and anesthesia equipment and the larger healthcare enterprise such as electronic health records. Some example profiles can be found on their website (www.ihe.net/Patient_Care_Devices) and are mentioned below: Alarm Communication Management Profile helps to ensure proper dissemination and prioritization of alarm messages from devices. Infusion Pump Event Communication profile allows an infusion pump to send detailed information to a larger care management system. Implantable Device Cardiac Observation profile allows two-way communication for interrogation and modification of cardiac devices. Rosetta Terminology Mapping profile allows mapping and correlation of disparate vendor terms and units of measure to ISO/IEEE 11073 standards. ASTM F2761: The official name for the ASTM F2761 standard is “Medical Devices and Medical Systems—Essential Safety Requirements for Equipment Comprising the Patient-Centric Integrated Clinical Environment” and is better known as ICE (Quigley, 2009). The standard aims to outline requirements so that devices produced by various manufacturers that are used in high acuity environments will be fully integrated and interoperable. The standard also extends to such monitoring devices that can be used in a patient’s home or other location outside of a hospital environment. Objectives of the standard include development of ICE network controllers that can send an alarm if the device is malfunctioning, ICE network supervisors which perform functions such as record keeping and clinical decision support, and ICE network interfaces which connect the devices with network controllers (Quigley, 2009). Health Information Technology Standards Panel: As mentioned above, the ONC founded the HITSP in 2005. HITSP is now a cooperative of public and private organizations (HITSP website). Its mission is to set integration and interoperability standards with the goal of a universal EHR. The guidelines endorsed by HITSP are meant to be mandatory for any organizations developing products, systems, or software for EHRs used in the U.S. Interoperability of remote monitoring devices is one focus of HITSP with its Interoperability Standard 77 (IS77). According to HITSP, the IS77 standard is concerned with data exchange and interoperability requirements for patient monitoring devices that are physically attached to or worn by a patient that is in a site remote from a physician (Consumer Perspective Technical Committee, 2008). Much like the ISO/IEEE 11073 standards, the IS77 standards allow for two-way communication between these remote patient monitoring devices and a centralized hospital information system. The standards define the syntax and semantics of messages regarding measurement of patient physiologic parameters, and define the messaging protocols for data about the function of the device itself. In addition, the patient, family member, or caregiver at the remote site may send additional messages to the physician or provider at the main hospital or medical center. Also, like the ISO/IEEE 11073 standards, the IS77 standards work in a system that connects the mobile devices to a device intermediary system. The device intermediary system interfaces with the mobile devices and collects and stores patient monitoring data. This is then connected to a remote monitoring management system which allows clinical personnel to select which data should then be forwarded to an EHR. The IS77 protocols allow for an alternative pathway for flow of information from the mobile devices to a personal health record (PHR) system or to a health information exchange organization. In this latter design it is assumed that data can then be transmitted from the PHR or health information exchange organization to the hospital EHR of the physician who ordered the 6 MOBILE DEVICES remote monitoring. Unlike ISO/IEEE 11073 standards, the IS77 standards only focus on interoperability between mobile devices and the EHR. They do not regulate the way data is captured on the device or how the data is transmitted from the device (i.e. Bluetooth, ZigBee, Wi-Fi) to the device intermediary system. Table 1 Summary of Mobile Device Standards and Standards Development Organizations Organization CEN/ISO/IEEE Standard 11073 family Continua Health Alliance multiple standards from various SDOs IHE multiple standards from various SDOs ASTM F2761 HITPS IS77 HL7 FHIR Uses total solution for two-way communication and data exchange between remote mobile devices and larger information systems consortium of multiple health and telecommunication enterprises; publishes guidelines for interoperability identifies standards and publishes guidelines for interoperability integration, control, and data acquisition standards for heterogeneous devices in acute care data exchange for monitoring devices worn by patients at remote sites combines HL7 messaging standards with web standards and web services Benefits cooperation among large and well-established SDOs; complete set of standards; wide international adoption concerned with building a system of interoperable mobile devices; certified products using widelyadopted standards offer plugand-play interoperability concerned with building interfaces for interoperability between a single device and a larger information system increased patient safety and workflow efficiency can transmit data to an EHR, PHR, or HIE organization makes HL7 standards easy to integrate into mobile device systems Mobile Health Device Adoption and Security With all the standards being put into place, the most effective approach to attaining rapid, wide acceptance for any of these standards in the U.S. is through third-party certification. This is extremely important because early compliance with the requirements and the security of data are of utmost importance. Brusco (2012) stated that as a result of the sophisticated devices and apps, accessing and transmitting patient data has increased dramatically, and, thus, there has been an increased concern about securing patient data and ensuring compliance with the Health Insurance Portability and Accountability Act (HIPAA) and the FDA proposed mobile health guidelines. Failure to comply with federal regulations could have significant ramifications, including fines and/or loss of a professional license. According to Brusco (2012), the guidelines have a narrow focus and are not intended for apps that address electronic health record functions, resource materials, general health, or general office operations. Instead, the guidelines are intended for three types of apps—“a mobile application that acts as an accessory to a regulated medical device, turns a mobile gadget into such a device or makes suggestions regarding a patient’s diagnosis or treatment,” (Mobile Devices, 2013). In February 2013, a set of standards for mobile applications were announced by Happtique. Happtique is an mHealth solutions company with the goal of integrating mobile health into patient care and daily life (PR Newswire 2013). They offer a suite of certified applications through mRx™ which gives a physician or other provider the ability to “prescribe” one or more mobile health applications appropriate to a patient’s condition. The patient “fills the prescription(s)” by uploading the recommended applications or acquiring the necessary devices. After publishing a final set of standards, Happtique will certify apps under the Happtique Health App Certification program (HACP). As mentioned in the PR Newswire article (2013), “HACP will help healthcare providers and consumers easily identify medical, health, and fitness apps that deliver credible content, contain safeguards for user data, and function as described”. 7 MOBILE DEVICES HACP is promising because it is already widely accepted due to the collaboration that it has garnered. For example, “the Association of American Medical Colleges (AAMC), CGFNS International, and Intertek will serve, according to their respective subject matter expertise, as HACP Partners responsible for the evaluation of health apps against the Certification Standards” (PR Newswire, 2013). Future Directions A future direction for mobile device interoperability standards is HL7’s Fast Healthcare Interoperability Resources (FHIR). This new standard that is now being developed by HL7 is meant to make implementing HL7 standards easier and more compatible with mobile standards (Brandt, 2012). According to the HL7 website, FHIR combines features of HL7 version 2, HL7 version 3, and the Clinical Document Architecture and web standards such as eXtensible Markup Language (XML), HTTP-based protocols and other web services protocols (HL7 FHIR website). With this combination of services and protocols it is hoped that FHIR will make HL7 healthcare standards interoperable with a wide variety of systems and devices and that implementation of systems using the standard can be deployed rapidly. Conclusions After conducting the various literature reviews, our research hypothesis stating that “mobile medical device standards for interoperability are neither well-established nor adopted” has not been disproven. There may be many contributing factors to this lag in adoption of standards for data exchange, but one significant factor is likely to be the highly competitive and growing consumer marketplace for medical devices which are marketed directly to consumers. As a result, manufacturers of mobile medical devices continue to focus on the device and not necessarily on the ability to exchange data with central health care systems. Despite this challenge, there could be steps taken to encourage interoperability in the near future. One approach to encouraging adoption of interoperability standards would be to incorporate a branded third-party certification and incorporate this requirement into prerequisites for reimbursement, mimicking the strategy used by the Meaningful Use program for encourage use and adoption of certified EHR’s. One candidate for a certification body is Happtique. Happtique has garnered the most global support by adopting an interoperability standard that includes the widely accepted HL7 version 3, the Clinical Document Architecture, and web standards such as XML and seems to have garnered the most global support. Happtique has focused on ensuring that both the mobile medical device and the mobile application that operates the device meet the requirements for interoperability. However, it may be difficult for Happtique to shed its image as a proprietary standard simply through participation of independent bodies. Many private companies have produced platforms that become de facto standards (Apple, Microsoft, et al), but they are frequently challenged at becoming a truly ubiquitous standard. As long as the use of mobile medical devices continues to grow and evolve, so will the proliferation of mobile health applications that take the incoming feed of data and try to convert it into a meaningful user interface. The biggest expectation of standardized mobile medical devices and their operating systems or mobile applications, is the potential in cost reduction for medical care. This potential will be difficult to fully realize without interoperability and extending beyond the individual user interface. If this type of interoperability is to be branded and certified as an important feature to the consumer, and therefore lead to adoption, privacy and security must be an important and explicit consideration. Patients must be confident that even with interoperability, they still have control over their data. Without this level of confidence, adoption of widespread interoperability will be a significant challenge. 8 MOBILE DEVICES References: Blumenthal D. Letter from ONC to HITSP. April 30, 2010. http://www.hitsp.org/doc/DBlumental_letter.PDF Brandt, J Jaffe, C, & Parker, C (2012). Standards and Interoperability. Retrieved November 3, 2013, from HIMSS Web Site: http://himss.files.cms-plus.com/FileDownloads/2013-mHIMSS-Roadmap-standards-interoperability.pdf Brusco J (2012). Mobile Health Application Regulations and Compliance Review. 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