Continua and IHE Joint Recommendation on Remote Monitoring

Transcription

1 Continua and IHE Joint Recommendation on Remote Monitoring Arto Holopainen - Mega Elektroniikka Oy Mega Elektroniikka Oy

2 Version One Healthcare Record Standards Disease Management Service Provider Continua xhr Interface (Data, Message, Security) Healthcare Provider Remote Patient Monitoring (RPM) Server Electronic Health Record System Labs Disease management nurse or home care nurse Document Standard: HL7 CCD Messaging Standard: HL7 v2.5 Home based Remote Patient Monitoring (RPM) System Patient Vital Sign Devices EHR 12 Continua has selected IHE Cross-Enterprise Document Reliable Interchange (XDR) profile as means to establish the communication between Wide Area Network (WAN) devices and Electronic/Personal Health Record (xhr) systems Teknologiakatsaus Continuassa kehitettävistä standardeista: XDR:

3 Joint Recommendation on base standards for HITSP RMON System Data Exchange #2 The Landscape Interface #2 Nomenclature: ISO/IEEE PHD Aligns with Continua Device Interface Interface #4 Data: PHM Specification (HL7 CDA based) Transport: IHE XDR Aligns with Continua EHR Interface Continua and IHE have agreed to a single set of content, transport, and vocabulary standards that work for all devices home-based and hospitalbased, simple and complex

4 Proposed Protocol Stack Device Intermediary Remote Monitoring Management System IHE and Continua WAN and HITSP RMON Interface #2 5 Content - HL7 v2.6 messages using IHE PCD-01 (Communicate PCD Data) Vocabulary - Constrained to IEEE/ISO / xx nomenclature Transport - Web Services transport based on WS-I Basic Profile PCD-01: WS-I:

5 Benefits of joint recommendation of remote monitoring This helps accelerate the deployment of convenient and reliable home-based health monitoring and care, and facilitates many other forms of remote monitoring as well. Together, Continua and IHE have finally made it possible for vendors of Medical Devices and Personal Health Devices to efficiently send patient data to the Personal and Electronic Health Records vendors using a single unified interoperability standard that is endorsed by HITSP., Elliot B. Sloane, Co-Chair IHE "The Continua Health Alliance appreciates the opportunity HITSP has afforded to work with IHE to provide a harmonized approach for the Remote Patient Monitoring Use Case with an open architecture, international, standards-based solution. This will facilitate an ecosystem of connected technologies, devices, and services that provide a compelling way to meet the challenges of increased access, improve outcomes for patients, and ultimately reduce overall healthcare costs. - Rick Cnossen, Continua

6 PCD Rosetta Project maps existing and proprietary vendor parameters and units-ofmeasure for virtually all physiological measurements to the ISO/IEEE vital signs nomenclature and related standards such as UCUM (Unified Code for Units of Measure). This will facilitate real-time interoperability between devices and systems, including EHR systems using the IHE PCD-01 Technical Framework. PCD Rosetta Project:

7 CEN/CLC SAMD Stockholm County Council/BEE 5 Revised MDD 2007/47/EC in effect March 21, 2010 medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

8 CEN/CLC SAMD Stockholm County Council/BEE 6 MDD 2007/47/EC cont diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; Software-only Products can meet the definition of a Medical Device Swedish report:

9 SW-only products 1. Define and Check the Intended Use Challenge: what data processing functionality makes the SW-only product intended to be used for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap? (taken from the MDD definition of Medical Device) Really any processing of patient data delivering output that can be used for one of these intended uses? Siemens AG Page 16 Oct 13, 2009 Dr. W. Leetz Healthcare / Germany / QT ST

10 SW-only Products Examples 1. Define and Check the Intended Use Hospital information systems assumed intended use: organizing the schedule for patient treatment, transfering data for administration and reimbursement not a Medical Device Decision support systems assumed intended use: processing patient data to offer a medical treatment Medical Device Radiotherapy planning systems SW separated from the SW that controls the radiotherapy equipment assumed intended use: calculate the dose of therapeutic application of ionizing radiation Medical Device Siemens AG Page 17 Oct 13, 2009 Dr. W. Leetz Healthcare / Germany / QT ST

11 SW-only Products Examples 1. Define and Check the Intended Use Picture archiving and communications systems intended use: archiving and transferring images for diagnosis and treatment of patients, including image enhancement Medical Device Virtual colonoscopy SW separated from the software that controls the CT-scanner software to acquire the DICOM images intended use: DICOM images are used to show the physical structure of the colon to allow the physician to identify relevant findings Medical Device Siemens AG Page 18 Oct 13, 2009 Dr. W. Leetz Healthcare / Germany / QT ST

12 Version One Healthcare Record Standards Disease Management Service Provider Continua xhr Interface (Data, Message, Security) Healthcare Provider Remote Patient Monitoring (RPM) Server Electronic Health Record System Labs Disease management nurse or home care nurse Document Standard: HL7 CCD Messaging Standard: HL7 v2.5 How ehealth and telemonitoring software is classified? Home based Remote Patient Monitoring (RPM) System Patient Vital Sign Devices EHR 12

13 Thank You!