Advancing Medical Device Interoperability (MDI)
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Presentation to accompany the white paper, Advancing Medical Device Interoperability: Operationalizing the Integrated Clinical Environment and Building the Environment for Medical Device Interoperability. Student: Brandon Lock Class: HESY 670 - Introduction to Health Information Systems Instructor: Dr. Hon Pak
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Advancing Medical Device Interoperability (MDI)
- 1. Advancing Medical Device Interoperability (MDI) HESY 670 – Introduction to Health Information Systems Department of Health Systems Administration Brandon Lock 1
- 2. Agenda • Key Questions • Overview of ICE/MDI Initiatives • Overview of ICE/MDI Stakeholders • Overview of Regulatory Environment • Key Findings 2
- 3. Agenda • Key Questions • Overview of ICE/MDI Initiatives • Overview of ICE/MDI Stakeholders • Overview of Regulatory Environment • Key Findings 3
- 4. Key Questions: • What is an Integrated Clinical Environment (ICE)? • What is Medical Device Interoperability (MDI)? • Why do we need ICE/MDI? • What are the Challenges & Barriers for ICE/MDI? 4
- 5. What is an Integrated Clinical Environment (ICE)? • Workflow Optimization • Systems Analysis & Engineering • Care Pathways & ClinicalWorkflow • Clinical Simulation • Pre-ClinicalTesting • Provider Education &Training • Interoperability • Medical Device Plug-and-Play (MD PnP) Program • Standards Development for Device Integration • EnablingTechnologies • “Smart” Algorithms & Automated Surveillance • WirelessTechnology Support (Sensors & Effectors) 5
- 6. What is Medical Device Interoperability (MDI)? Medical Device Interoperability: The ability for medical devices to communicate with other medical devices; or information systems that ultimately leads to or enables secure, safe, and effective use. (MDICC) Functional Medical Device Interoperability: The ability for clinical medical devices to communicate in a consistent, predictable and reliable way, allowing for the exchange of, and interaction with, data from other medical devices and with patient data sources and repositories, such as electronic health records (EHRs), in order to enhance device and system functionality. (WHI) 6
- 7. Why DoWe Need ICE/MDI? • Healthcare Delivery is High Risk • DHS Critical Infrastructure Sector • FDA Regulated Medical Devices are Mission-Critical Safety-Systems • Healthcare Delivery is Costly & Fragmented • Need to Improve Safety, Quality, & Efficiency • Need to Network, Coordinate, & Connect • PromisingValue of HIT • Enterprise-Wide Interoperability • HIT Integration into ClinicalWorkflow 7
- 8. What are the Challenges & Barriers for ICE/MDI? • Financial • Lack of Incentive Structuring for Interoperability • Regulatory Burdens for Medical Device Manufacturers & Purchasers • Connectivity • Lack of Interconnection between Medical Devices & Clinical Information Systems (CIS) • Lack of Established Standards for Uniform Medical Device Interoperability • Health Delivery • Limits in Human Factors Engineering (HFE) of Medical Devices and System/Process Failures • Balancing Customization, Standardization, Clinical Workflow, & Ease of Provider Delivery 8
- 9. Igniting an Interoperable Healthcare System HCI | DC 2014 Healthcare Innovation Day 9
- 10. Connecting Health & Care for the Nation A Shared Nationwide Interoperability Roadmap 10
- 11. Agenda • Key Questions • Overview of ICE/MDI Initiatives • Overview of ICE/MDI Stakeholders • Overview of Regulatory Environment • Key Findings 11
- 12. Overview of ICE/MDI Initiatives • 1998 -The Center for Integration of Medicine & InnovativeTechnology (CIMIT) • Integrated Clinical Environments (ICE) Initiative • Clinical Systems Innovation (CSI) Program • 2004 -The Medical Device Plug-and-Play (MD PnP) Interoperability Program • 2012 –The Medical Device Interoperability Council (MDICC) • 2013 –The Center for Medical Interoperability (C4MI) 12
- 13. MD PnP Interoperability Program Projects • Developing a New Open Standard for a Patient-Centric “Integrated Clinical Environment” (ICE) • Defining a Safe Regulatory Pathway for Patient-Centric Networked Medical Devices • Creating and Refining Interoperability Contracting Language • Performing Detailed Workflow & Gap Analysis • Developing a Prototype Healthcare Intranet (IoT) 13
- 14. MD PnP – Open ICE 14 • Open Integrated Clinical Environments (ICE) Open-Source Digital Research Platform •Open ICE Equipment Interfaces Translate Proprietary Manufacturer- Specific Interfaces to Common Data Representation and Communication Protocol •Devices are Plug-and-Play using Software Device Adapters (SDAs)
- 15. MD PnP – Prototype Healthcare Intranet • The creation of an eco-system for interoperability of medical device and clinical information systems to support innovation in patient safety and healthcare quality with an Open ICE Platform. • Interoperability of devices and IT systems in clinical environments will permit: • Mixed-Vendor DataTransfers • Comprehensive Secure Data Acquisition • Safety-Enhancing Capabilities • Safety Interlocks • Closed-Loop Device Control 15
- 16. Agenda • Key Questions • Overview of ICE/MDI Initiatives • Overview of ICE/MDI Stakeholders • Overview of Regulatory Environment • Key Findings 16
- 17. ICE/MDI Stakeholders • Patients • Health Delivery Organizations (HDOs) • Medical Device Manufacturers • Regulatory Agencies • FDA, FCC, NIST,ONC, HHS, etc. • Trade Associations • Standards Developing Organizations (SDOs) • Academic Institutions • Teaching Hospitals, Labs, & Universities 17
- 18. ICE/MDI Stakeholder Development Map 18 Center for Medical Interoperability 2013 Health Systems $ Health Systems + Universities + Laboratories Center for Integration of Medicine & InnovativeTechnology 1998 Federal Government Regulatory + Medical Device Industry + Standards Development Organizations (SDOs) + Trade Associations + Academia/Research Medical Device Interoperability Coordinating Council 2012 $ The ICE Alliance SDOs + Manufacturers + Healthcare & Clinical
- 19. Agenda • Key Questions • Overview of ICE/MDI Initiatives • Overview of ICE/MDI Stakeholders • Overview of Regulatory Environment • Key Findings 19
- 20. Overview of Regulatory Environment • Operational Regulations • Clinical • Technical • Commercial • Information Security • Regulatory Compliance • Incentive Programs • Tax & Approval 20
- 21. Operational Regulatory Environment 21 ONC 2015 Interoperability Standards Advisory GAO Draft Shared Interoperability Road Map (2015) EHR: Nonfederal Efforts to Help Achieve Information Interoperability (2015) HITECH 2009 ACA 2010 TRUST IT 2015 Impact on ICE/MDI • Standards • Security Protections • Supportive Regulatory Environment AAP AHA Vendor ImpactProvider Impact
- 22. Agenda • Key Questions • Overview of ICE/MDI Initiatives • Overview of ICE/MDI Stakeholders • Overview of Regulatory Environment • Key Findings 22
- 23. Key Findings • Operationalizing the Integrated Clinical Environment (ICE) • ClinicalWorkflow Optimization • Clinical Simulations &Vendor-Neutral SandboxTesting • Leveraging EnablingTechnologies • Reference Compendium of Medical Device Interface Capabilities & Data Elements • Building the Environment for Medical Device Interoperability (MDI) • Develop & Promote Open Standards • Define Safe Regulatory Pathways • Enable Device Integration • Build an Integrated Medical Device Intranet 23
- 24. Operationalizing the Integrated Clinical Environment (ICE) • Clinical WorkflowOptimization • Clinical Simulations &Vendor-Neutral SandboxTesting • Leveraging EnablingTechnologies • Reference Compendium of Medical Device Interface Capabilities & Data Elements 24
- 25. Building A Bridge for Medical Device Interoperability 25 Health Delivery Organizations (HDOs) Current Environment Standard Developing Organizations (SDOs) Future State of Health Delivery Medical Device Manufacturers Device Integration Safe Regulatory Pathways Clinical Simulation Sandbox Capabilities Reference Compendium Integrated Clinical Environment (ICE) Data Logger “Black Box” ForensicAnalysis
- 26. Building an Environment for Medical Device Interoperability (MDI) 26 • Develop & Promote Open Standards • Define Safe Regulatory Pathways • Enable HDO Device Integration • Build an Integrated Medical Device Intranet
- 27. Develop & Promote Open Standards 27 • Standards Goals for HIT • Interoperability • Portability • Exchangeability • Types of HIT Standards • Vocabulary &Terminology Standards • Standards for Electronic Data Exchange • Health Record Content & Functional Standards
- 28. Develop & Promote Open Standards • Standards Development for Device Integration • Device-Generated Data • EMR Observational & Procedural Data • Alignment with Local, Regional, & National EMR Initiatives • Articulation of future clinical states to ensure that proposed technical solutions and standards will yield useful clinical capabilities. • Interoperability among Medical Devices • Interoperability among components of Integrated Medical Device Systems • Interoperability among Medical Devices & EHRs • Interoperability among Medical Devices & Hospital IT/Clinical Information Systems • Interoperability among Personal Medical Devices &Telehealth Data Hubs 28
- 29. Define Safe Regulatory Pathways • Define Safe Regulatory Pathways for Patient-Centric Networked Medical Devices • FDA Draft Guidance & Interoperability WorkGroups • Example: Medical Device Interoperability Coordination Council (MDICC)Clinical Needs & Clinical LandscapeTeam (2010) • Example:Guidance Document to Assist Industry in Conducting Appropriate Human FactorsTesting & Identifying Device Feature OptimizationThroughTotal Product Life Cycle (2011) 29
- 30. Enable HDO Device Integration • Developing an HIT Safety Administration (HITSA) • Developing Medical Device Interface Data Sheets (MDIDS) • Developing Open ICE Data Logger System • ForensicAnalysis of Safety-Critical Systems • ICE Black Boxes 30
- 31. Build an Integrated Medical Device Intranet • The creation of an eco-system for interoperability of medical device and clinical information systems to support innovation in patient safety and healthcare quality with an Open ICE Platform. • Interoperability of devices and IT systems in clinical environments will permit: • Mixed-Vendor DataTransfers • Comprehensive Secure Data Acquisition • Safety-Enhancing Capabilities • Safety Interlocks • Closed-Loop Device Control 31
- 32. What Can ICE Platforms Deliver? • ICE Platforms Can Enable Revolutionary Improvements • Patient Safety • Rich Clinical Data Availability • Innovation through Interoperable Apps, Sensors, & Actuators • Operations & Logistics • Cybersecurity of Medical Devices & HIT 32
- 33. What Can MDI Deliver? 33
- 34. Questions? 34 Contact: Brandon Lock Email: bjl64@georgetown.edu
Editor's Notes
- Purpose: The purpose of this presentation is to provide background on the clinical, technical, commercial and regulatory challenges involved with deploying health information technology (HIT) to operationalize the integrated clinical environment (ICE) and advance medical device interoperability (MDI). Further, this presentation identifies areas for improvement, the current solutions landscape and future benefit state as a result of advancing MDI and operationalizing ICE at the point-of-care.
- Reference: Center for Integration of Medicine & Innovative Technology (CIMIT) Integrated Clinical Environments (ICE) Initiative https://www.cimit.org/images/programs/ICE.pdf
- Connected Devices: Philips Intellivue Series Monitors Serial (RS-232) and Ethernet GE Solar 8000x / Dash 4/5000 Dräger Apollo / EvitaXL / V500 Nonin Bluetooth OnyxII 9650 / WristOx 3150 Oridion Capnostream20 Ivy 450C Nellcor N-595 Masimo Radical-7 Fluke Prosim6/8 Patient Simulator References: Julian M. Goldman, MD, Presentation on Medical Device Interoperability to Enable Healthcare Transformation or The Medical IoT (MIoT) June 4th 2015 West Health Institute. The Value of Medical Device Interoperability: Improving Patient Care with more than $30 Billion in Annual Health Care Savings. March 2013
- Healthcare Delivery is High Risk: The Department of Homeland Security (DHS) defines Critical Infrastructure Sectors (CIS) as those whose assets, systems, and networks, whether physical or virtual, are considered so vital to the US that their incapacitation or destruction would have a debilitating effect on security, national economic security, national public health or safety, or any combination thereof. Safety-critical technologies such as medical devices should eliminate or reduce design-related use problems that contribute to or cause unsafe or ineffective medical treatment which should be part of a process for controlling overall risk. For devices where harm could result from “use errors,” the dynamics of user interaction are safety-related and should be components of risk analysis and risk management. Healthcare Delivery is Costly & Fragmented: Healthcare delivery is not only fragmented by the types of providers, but is also fragmented in payment, technology, and regulation. In the US market this can lead to proprietary information silos, errors in care transition, and the inability to exchange information. Landmark IOM Reports have indicated the need to improve safety, quality, and efficiency within Healthcare. Promising Value of HIT: Enterprise-Wide Interoperability HIT Integration into Clinical Workflow
- Financial: Lack of Incentive Structuring in a Mixed-Vendor Environment Regulatory Burdens for Medical Device Manufacturers & Purchasers Connectivity: Lack of an Intranet Ecosystem to Interconnect Medical Devices & Clinical Information Systems Lack of Established Standards for Uniform Medical Device Interoperability Problems with information management with data stored in many ways, locations, and often in silos. Clinical decisions based on invalid or out-of-date information can have disastrous consequences Health Delivery: Understanding and optimizing how people interact with technology is the subject of human factors engineering (HFE) and usability engineering (UE). HFE/UE considerations that are important to the development of medical devices include three major components of the device-user system: (1) device users, (2) device use environments and (3) device user interfaces. The purchasers of medical devices and HIT systems (Hospitals and Health Systems) have data sharing needs, but do not have the ability to legally and financially induce-demand for interoperability because of proprietary/protected information systems. This problem is compounded by purchasers, often-limited, understanding of medical devices and HIT systems
- Reference: West Health Institute & Office of the National Coordinator Igniting an Interoperable Healthcare System HCI | DC 2014 Healthcare Innovation Day
- Federal HIT Efforts: The passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009 was the first of several high-visibility efforts undertaken by the federal government to accelerate the adoption and integration of information technology into healthcare. ONC is one of many federal agencies working to solve the challenges facing ICE/MDI. Reference: Office of the National Coordinator (ONC) Connecting Health & Care for the Nation: A Shared Nationwide Interoperability Roadmap (Final Version), https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf
- The Center for Integration of Medicine & Innovative Technology (CIMIT) It was created in 1998 as a consortium designed to accelerate the pace of research and development by leveraging technological expertise from industry and academia for targeted medical applications. The goal was to provide seed funding for early-stage, high-risk ideas leveraged by the experience of commercialization experts to facilitate the progress of multidisciplinary teams focusing on translational research. The Medical Device Interoperability Council (MDICC) It was formed in 2012 and is an open forum to allow collaboration between stakeholders that are actively engaged in aspects of promoting or creating interoperable medical device systems. The forum’s mission is to advance wide adoption of medical devices that seamlessly interoperate with other medical devices and information systems with the goal of enabling improved patient care. The Center for Medical Interoperability It was formed in 2013 and is a 501(c)(3) organization led by health systems to change how medical technologies work together by solving the shared technical challenges health systems face in integrating medical devices, electronic health records and information technology systems in a plug-and-play way.
- Developing a New Open Standard for a patient-centric “Integrated Clinical Environment” (ICE) To define the conditions under which interoperability can enable device integration to create new medical device systems with greater safety and performance capabilities than any individual device. Part 1 of the ICE standard was published as ASTM F2761-09, and is providing a valuable framework for further defining the vision and clinical content for other standards. Defining a Safe Regulatory Pathway for Patient-Centric Networked Medical Devices In partnership with the FDA the group has co-sponsored workshops held by FDA in January 2010 on medical device interoperability, followed by a working group of companies, academics, and hospitals that have developed and submitted a pre-IDE regulatory submission to help refine the FDA clearance process. Creating and Refining Interoperability Contracting Language For use by hospitals in their procurement of medical devices (MD FIRE: Medical Device Free Interoperability Requirements for the Enterprise) Performing Detailed Workflow & Gap Analysis Of use cases with a team of MD PnP Collaborators (including medical device companies) and analyzing the ability of existing standards to meet these requirements (gap analysis), yielding important understanding of the capabilities and limitations of existing interface standards. Developing Demonstration Implementations of Clinical Use Cases This is allowing integration of the clinical environment to improve patient safety and showing these at major clinical and health IT conferences. Developing a Prototype Healthcare Intranet Using an open ICE platform and tools to ensure safe and effective connectivity of medical equipment and decision support for clinical care. This open prototype research platform could support evaluations by the FDA of interoperable medical device systems and serve as a generic model that could be shared with other organizations. Reference: The Medical Device Plug-and-Play (MD PnP) Interoperability Program White Paper, http://www.mdpnp.org/uploads/Oct12_MD_PnP_White_Paper.pdf
- Open ICE Digital Research Platform: Based on ASTM F2761 “Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) IEEE 11073 Nomenclature OMG DDS Pub/Sub Messaging Middleware New version is built on open source implementation of open standards. Open ICE equipment interfaces translate proprietary manufacturer-specific interfaces to common data representation and communication protocol Better patient simulator allows patient algorithms to plug in Devices are plug-and-play: any device that provides necessary interface can be used Reference: Julian M. Goldman, MD, Presentation on Medical Device Interoperability to Enable Healthcare Transformation or The Medical IoT (MIoT) June 4th 2015
- Developing a Prototype Healthcare Intranet (IoT): The Vision of the NIH/NIBIB Quantum Medical Device Interoperability (QMDI) Grant is to create deliverables that will spark creation and adoption of innovative healthcare applications, systems, and medical devices that enable safer and more effective care through medical device interoperability. MD PnP is using an iterative process based on industry best practices of System Engineering and Quality Development Processes to allow clinicians and clinical engineers to communicate clinical needs and assess milestones in an effective way to developers, and will produce deliverables that are both useful and re-usable by the adoption community. PCA Safety Interlock: example of component-level medical device interoperability to improve safety of medication infusions; multi-parameter “smart alarms” ICU Preparedness: example of ability to support safer in-hospital patient transfer & dynamic checklists to reduce errors Telehealth devices in hospital: example of transferring care from home to hospital and use of devices for high-acuity care FDA Regulatory/Safety: sedation for G.I. procedure as a framework for levels of interoperability and associated levels of hazards and their mitigation Reference: Julian M. Goldman, MD, Presentation on Medical Device Interoperability to Enable Healthcare Transformation or The Medical IoT (MIoT) June 4th 2015
- Stakeholders: Clinicians Engineers Healthcare Delivery Organizations (HDOs) Standards Developing Organizations (SDOs) Health Information Exchanges (HIEs) Regulatory Agencies Medical Device Manufacturers Interoperability Promoting Organizations
- Center for Integration of Medicine & Innovative Technology (1998) *Founding Institution Beth Israel Deaconess Medical Center Boston Medical Center Boston University Brigham & Women’s Hospital* Children’s Hospital Boston Draper Laboratory* Harvard Medical School Massachusetts General Hospital* Massachusetts Institute of Technology* Newton-Wellesley Hospital Northeastern University Partners Healthcare VA Boston Healthcare System Medical Device Interoperability Coordinating Council (2012) American Society for Testing and Materials (ASTM) West Wireless Health Institute (WWHI) Department of Veteran Affairs (VA) & Department of Defense (DoD) Continua Health Alliance Anson Group Healthcare Information and Management Systems Society (HIMSS) Association of Medical Instrumentation (AAMI) Advanced Medical Technology Association (AdvaMed) Microsoft IHE Patient Care Device Domain (IHE PCD) American Health Information Management Association (AHIMA) NIH – mHealth UL Life & Health Sciences Medical Imaging & Technology Alliance (MITA) Qualcomm International Electrotechnical Commission (IEC-TC 62) National Institute of Standards & Technology (NIST) Kaiser Health Systems Institute of Electrical and Electronics Engineers (IEEE) Health Level Seven International (HL7) Phillips Healthcare Partners Healthcare Food & Drug Administration – Center for Devices and Radiological Health (FDA-CDRH) Center for Medical Interoperability (2013) *Board Members (Non-Official Organization Partners) Gary & Mary West Health Institute John Hopkins University* Cedars-Sinai Health System* Robert Wood Johnson Health System* Northwestern Memorial HealthCare* Vanderbilt Health*
- Regulatory Environment: Outside the scope of this paper and presentation, however developing process maps of the regulatory environment would be helpful for advancing ICE/MDI going forward. Key: Blue – Agency/Organization White – Agency/Organization Product Red – Legislation Green – Trade Associations Reference: United States Government Accountability Office. Electronic Health Records: Nonfederal Efforts to Help Achieve Health Information Interoperability. September 2015. http://www.gao.gov/assets/680/672585.pdf Office of the National Coordinator. Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap. Final Version 1.0. https://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf Office of the National Coordinator. 2016 Interoperability Standards Advisory. Draft for Comment. https://www.healthit.gov/sites/default/files/2016_InteroperabilityStandardsAdvisoryFINAL.pdf
- Workflow Optimization: Systems analysis and engineering to improve care pathways and clinical workflow based on “what should and could be”, and not limited to “what is”. CIMIT will leverage the system engineering and operational expertise of its members along with its experience with “learning laboratories” in clinical settings at all levels of acuity, from ICU to homecare. Clinical Simulation: High fidelity patient and clinical environment simulations based on the CIMIT ICE projects to develop insights into improvement opportunities, validate performance and safety, and support dissemination and training. The initial focus will be pre‐clinical testing, and subsequently we will look at simulation as part of routine workflow and provider education, as well as techniques to rapidly educate the diverse healthcare delivery workforce. CIMIT will leverage the experience with healthcare simulation technologies throughout the Boston academic community, consolidating expertise across technologies, curriculum, and human factor domains. CIMIT will catalyze innovation across the strong network of member Simulation Centers, including the Center for Medical Simulation, to embed simulation‐based learning across clinical settings. Interoperability: CIMIT will build on the international leadership and network of collaborators in this domain through its Medical Device Plug‐and‐Play (MD PnP) Program, with a focus on: Standards development for device integration, including for device‐generated data, EMR observational and procedural data, and alignment with ongoing local, regional and national EMR initiatives Interoperable modalities and a repository of interoperability‐related “clinical scenarios” generated through clinical experience for key medical devices and systems such as PCA pumps and respiration monitors. These scenarios will guide and stimulate development projects that improve outcomes and patient safety. Enabling Technologies: CIMIT will leverage its numerous sponsored projects and those at its member institutions to develop and adapt technologies that address clinical needs, and will lead by example, such as with projects that address: “Smart” algorithms that process integrated data from devices and the EMR in a manner that efficiently empowers each level of caregiver to make better decisions, as well as allowing automated surveillance of patient status Wireless technologies that support communication and can encompass wearable sensors and effectors Devices and systems for appropriately and unobtrusively extending medical care systems to lower‐acuity settings, including the home; not just moving complex hospital technologies directly to these settings Reference: Center for Integration of Medicine & Innovative Technology (CIMIT) Integrated Clinical Environments (ICE) Initiative https://www.cimit.org/images/programs/ICE.pdf
- Health Care Bridge Analogy Dr. Paul Tibbits Deputy CIO for Architecture, Strategy, and Design Department of Veteran Affairs Black Box Capabilities: Planes, trains, and automobiles have “black box recorders” – or “data loggers” to support forensic data analysis in safety critical systems. We believe that this capability is essential for clinical environments as well. As described in standard ASTM F2761-09 on the Integrated Clinical Environment (ICE), even-logging functionality is necessary to address regulatory and liability concerns regarding networked medical device systems, and will also improve the forensic analysis of clinical adverse events and near misses. Future State: National vision of using comprehensive, accurate, electronic medical records and HIT systems to improve the quality and efficiency of healthcare.
- High Level Overview of Developing Open Standards: Goals Interoperability Portability Data Exchange Types of Health Information Standards Classification Standards Vocabulary & Terminology Standards National Committee on Vital & Health Statistics (NCVHS) Uniform Data Standards for Patient Medical Record Information (PMRI) SNOMED-CT LOINC RxNorm (National Library of Medicine) UMLS (National Library of Medicine) Standards for Electronic Data Exchange Purpose is to standardize the actual messaging between two HIS HL7 DICOM NCPDP ANSI ASC X12N Health Record Content & Functional Standards HL7 EHR-S Functional Model Result of 2009 revision and outlines important features and functions in EHR. Framework to describe and drive requirements and application of next level standards. ASTM Health Record Content Standards Continuity of Care Document (CCD) Standard for the exchange of patient summary information, “Transportable Patient Care Information”. Product merger of HL7 CDA and ASTM CCR HITECH EHR Certification Criteria Standards Development Process Ad Hoc (e.g. DICOM) De Facto (Product become the Norm e.g. XML) Government Mandated (e.g. HIPAA, HL7) Consensus (e.g. ISO, ASTM, HL7) Open Integrated Clinical Environment (ICE) – ASTM F27601-09 Health Level Seven International (HL7): A not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. "Level Seven" refers to the seventh level of the International Organization for Standardization (ISO) seven-layer communications model for Open Systems Interconnection (OSI) - the application level. The application level interfaces directly to and performs common application services for the application processes. Although other protocols have largely superseded it, the OSI model remains valuable as a place to begin the study of network architecture. Healthcare Information Technology Standards Panel (HITSP) changed in 2009 to Healthcare Information Technology Standards Committee (HITSC), serves as a cooperative partnership between the public and private sectors for the purpose of achieving a widely accepted and useful set of standards specifically to enable and support widespread interoperability among healthcare software applications, as they will interact in a local, regional and national health information network for the United States.
- Reference: The Medical Device Plug-and-Play (MD PnP) Interoperability Program
- Reference: FDA Guidance Documents http://www.fda.gov/RegulatoryInformation/Guidances/ucm259748.htm
- MD PnP Proposal for HIT Safety Administration” (HITSA) (April 2014) A public-private partnership that could, in collaboration with vendors, hospitals, FDA, NIST, ONC and FCC (and NLM and NSF) provide a convening environment and test bed for HIT systems prior to deployment and for solving problems when they develop. Proposed standards and technologies could be assessed and problems addressed prior to adoption. Root cause analysis of adverse events and near misses could be performed in collaboration with vendors, as needed. Product defects or configuration problems could be addressed horizontally and solutions coordinated across industry, instead of by each hospital-vendor pair. Facilitation of adverse event analysis involving HIT systems may require the application of technologies that have been successful elsewhere, such as “black box” recorders for network medical device/HIT data. Implementation of truly interoperable and safe medical device/EMR systems will lower the cost of health care and accelerate innovation. This approach to safety can also provide the US with a healthcare manufacturing leadership opportunity. MD PnP Project Medical Device Interface Data Sheets (MDIDS) Developing a reference compendium of medical device interface capabilities and data elements which could enable more complete, effective, and safe device integration. The Medical Device Interface Data Sheets (MDIDS) will serve as a reference for standards development organizations (SDOs), manufacturers, researchers, and clinical organizations. MDIDS include both "generic" and device-type sheets Generic: The generic sheet includes device identification data such as Serial Number, FDA-mandated Universal Device ID (UDI), software version numbers, and a description of the data encoding used for device-specific data elements. Other categories of data found in generic MDIDS are Patient Identification and Location information, as well as data about the Operating Conditions of the device and its Configuration. MD PnP Project Data Logger (June 2014): Implementing a basic open-source ICE Data Logger that will capture device and use data intended to facilitate analysis of adverse events and enable other types of analysis of device networks. MD PnP is working to develop a functional prototype Data Logger that will capture data from medical devices in a time-synchronized, standardized, and trustworthy manner. This work will preview the power of these emerging capabilities, as existing standards do not yet support all the data that is needed from devices for recording and later analysis.
- Developing a Prototype Healthcare Intranet (IoT): The Vision of the NIH/NIBIB Quantum Medical Device Interoperability (QMDI) Grant is to create deliverables that will spark creation and adoption of innovative healthcare applications, systems, and medical devices that enable safer and more effective care through medical device interoperability. MD PnP is using an iterative process based on industry best practices of System Engineering and Quality Development Processes to allow clinicians and clinical engineers to communicate clinical needs and assess milestones in an effective way to developers, and will produce deliverables that are both useful and re-usable by the adoption community. PCA Safety Interlock: example of component-level medical device interoperability to improve safety of medication infusions; multi-parameter “smart alarms” ICU Preparedness: example of ability to support safer in-hospital patient transfer & dynamic checklists to reduce errors Telehealth devices in hospital: example of transferring care from home to hospital and use of devices for high-acuity care FDA Regulatory/Safety: sedation for G.I. procedure as a framework for levels of interoperability and associated levels of hazards and their mitigation Reference: Julian M. Goldman, MD, Presentation on Medical Device Interoperability to Enable Healthcare Transformation or The Medical IoT (MIoT) June 4th 2015
- Some IA Deliverables already in progress through MD PnP Program: Medical and Health IT equipment procurement language for use by healthcare delivery organizations (MD FIRE) Clinical Needs Assessment and Descriptions – by HDOs System Requirements Specifications – elaborated by MD PnP program Use Case and Clinical Scenario Library – maintained by MD PnP ICE reference implementations, including safety and security requirements, and test tools – Started by MD PnP Feedback to Standards Development Organizations (SDOs) to help standards conform to ICE requirements – currently performed by MD PnP Regulatory science analysis related to submission ICE Alliance: Is a non-profit organization in the global healthcare/eHealth industry, promoting the development and market acceptance of initiatives and work product that promote clinical environments that are safe, secure, and interoperable, in compliance with ASTM’s ICE industry standard and leveraging work of MD PnP. http://www.ieee-isto.org/member-programs/ice-alliance#sthash.gXfPFy1z.dpuf Reference: Julian M. Goldman, MD, Presentation on Medical Device Interoperability to Enable Healthcare Transformation or The Medical IoT (MIoT) June 4th 2015
- What Can MDI Deliver?: Compliance with Meaningful Use Qualification for Incentive Payments under MACRA 2015 In Summary: There are significant benefits at stake for healthcare delivery to be realized by operationalizing the integrated clinical environment (ICE) and advancing medical device interoperability (MDI) at the point-of-care. There are numerous operational and regulatory challenges involved with this type of transformation due to its multidimensional nature, the involvement of competing stakeholders, lack of semantic uniformity in standards/technology, and the structure of the supporting financial environment. The future state of ICE/MDI is to have open, interoperable, and securely networked medical devices working through a Medical IoT platform in tandem with sensors, actuators, and analytic software engines to transform data into actionable knowledge delivered to a provider to make informed clinical decisions in order to deliver the most efficient, highest quality, and safe care to patients. Collaboration is the non-negotiable imperative to advancing this future state and stakeholders need to advocate, promote, and continue to build the business case for advancing ICE/MDI in order to gain traction in an environment of competing financial needs.