This document discusses trends, standards, and the future of medical software. It covers definitions of medical devices and various medical software systems. Standards like DICOM, HL7, IHE, and CCOW that promote medical data sharing are summarized. Development challenges and future trends involving cloud storage, remote diagnosis, and integrated multimodality workflows are outlined in less than 3 sentences.

1. Medical software Trends, Standards & Future SREEDHAR KODLAHALLI BANGALORE, INDIA 10 OCTOBER 2011 A sand-box of all things Medical…

2. Medical software - Medical Device : Definition "Medical device" means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: 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. Medical software - Trends, Standards & Future Sreedhar Kodlahalli

3. Medical software - Lexicon HIS - Hospital Information System CIS - Cardiology Information System RIS - Radiology Information System PACS - Picture Archiving and Communication System Modality - Image acquisition hardware (CT / MR / US / X-ray) Workstation - Image viewing/processing entity LTS - Long-term storage STS - Short-term storage ADT - Admission/Discharge/Transfer Medical software - Trends, Standards & Future Sreedhar Kodlahalli

4. Medical software - Healthcare segments Imaging (e.g., CT, MRI, US …) Information systems (e.g., clinical, operational, financial) Non-invasive therapy Invasive therapy Medical implants (e.g., heart valve) Home/Personal care Pharma/Labs Referring physician, billing, insurance Medical transcriptions Medical software - Trends, Standards & Future Sreedhar Kodlahalli

5. Medical software - Traditional medical ‘ologies’ Radiology - Diagnose and treatment of diseases using medical imaging technologies (radiant energy and radioactive substances) Oncology - Diagnose and treatment of tumors Cardiology - Diagnose and treatment of heart and its diseases Angiology - study of blood vessels and lymph (a clear, watery, sometimes faintly yellowish fluid derived from body tissues that contains white blood cells) vessels Ophthalmology - study of anatomy, physiology and pathology of the eye Medical software - Trends, Standards & Future Sreedhar Kodlahalli

6. Medical software - Current trends Workflow enabled Establishes a seamless flow of information that supports efficient patient care workflow in a typical imaging encounter maintaining the consistency of patient information Context aware Process of using particular "subjects" of interest (e.g., user, patient, clinical encounter etc.) to 'virtually' link disparate applications so that the end-user sees them operate in a unified, cohesive way Data driven / Role based Appropriate selection of tools and processes based on the selected data and the role executing the data Medical software - Trends, Standards & Future Sreedhar Kodlahalli

7. Medical software - Statutory regulations/ Certifications Medical standards ISO 14971 - Application of risk management to medical devices ISO 13485 - Quality management standard for medical devices Hardware CE 0413 marking Regulatory approvals FDA - Food & Drug Administration, USA TÜV - Technische Überwachungs-Verein, European Union CFIA - Canadian Food Inspection Agency, Canada JPAL - Japanese Pharmaceutical Affairs Law, Japan Medical software - Trends, Standards & Future Sreedhar Kodlahalli

8. Medical software - Systems & information flow Medicare Provider Inventory Admission/Discharge/Transfer RIS PACS Workstation HIS Modality Master Patient Index Medical software - Trends, Standards & Future Sreedhar Kodlahalli

9. Medical software - Typical Workflow Medical software - Trends, Standards & Future Sreedhar Kodlahalli

10. Medical software - Workflow steps Registration Order Scheduling Image acquisition Pre-processing / QC Image archival Post-processing / measurements / QC Reading / reporting / billing Referring physician Therapy / out-patient care / follow-up Medical software - Trends, Standards & Future Sreedhar Kodlahalli

11. Medical software - IHE Radiology Workflow *Picture Ref: IHE – Radiology Workflow – Present & Future Extensions EuroPACS 2002 Conference – Oulu / Finland * Medical software - Trends, Standards & Future Sreedhar Kodlahalli

12. Medical software - Systems / Roles To ensure Data availability Consistency Medical software - Trends, Standards & Future Sreedhar Kodlahalli

13. Medical software - Worklists Essence of workflow-enabled, context-aware, data-driven systems Consists of Workitems - a unit of action/process to be followed Lists provided for each human/machine actor based on the role and rules Rule based : Set of filters based on actors preferences, organizational processes and patient priorities Actors can choose to sort & search the worklists and override the presented order of work items (human factor) Examples of Worklists Medical software - Trends, Standards & Future Sreedhar Kodlahalli

14. Medical software - Industry inter-operability standards HIPAA - Health Insurance Portability and Accountability Act Encourages the widespread use of electronic data exchange in the US health care system to improve the efficiency and effectiveness DICOM - Digital Imaging and Communications in Medicine Standard for handling, storing, printing, and transmitting information in medical systems HL7 - Health Level 7 Standards for interoperability that improve care delivery, optimize workflow, reduce ambiguity and enhance knowledge transfer. Based on short messages IHE - Integrating the Healthcare Enterprise An initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information CCOW - Clinical Context Object Workgroup An HL7 standard protocol designed to enable disparate applications to synchronize in real-time, and at the user-interface level. Facilitates "Context Management” Medical software - Trends, Standards & Future Sreedhar Kodlahalli

15. Medical software - Standard : HIPAA Privacy & Security The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information The HIPAA Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes (read insurance) The HIPAA Security Rule requires that healthcare organizations implement audit controls. The five steps to meeting this requirement include Determine systems or activities to be tracked or audited Select the tools that will be deployed for auditing and system activity reviews Develop and deploy the Information System Activity Review and Audit Policy Develop appropriate standard operating procedures Implement the audit/system activity review process Medical software - Trends, Standards & Future Sreedhar Kodlahalli

16. Medical software - Standard : DICOM Hierarchy Patient Study Series Image Procedure - One or more Series from one or more Studies DICOM Service Object Pair (SOP) - Classes and the roles of Service Class User (SCU) and Service Class Provider (SCP) Verification service class SCP/SCU roles Storage service class SCP/SCU roles Query/Retrieve service class SCP/SCU roles Medical software - Trends, Standards & Future Sreedhar Kodlahalli

17. Medical software - Standard : DICOM salient features Confirmation statement : A standardized way of identifying the specific DICOM capabilities of the equipment (supported SOP pairs - SCU/SCPs) Self contained entity - Preamble, Header & Image(s) Standard tags Unique IDs for various tag values (e.g., SeriesInstanceUID, PatientUID) Universal DICOM dictionaries for tags and custom tags Ability to store single frame and multi frame medical images Format extendable by design Parts (e.g. Part10 - Media Storage and File Format for Media Interchange) Supplements (e.g. Supplement 60 - Hanging Protocol) Medical software - Trends, Standards & Future Sreedhar Kodlahalli

18. Medical software - Standard : HL7 HL7 provides Functional interoperability Semantic interoperability Based on messages "Level Seven" refers to the top level of the seven-layer International Standards Organization's (ISO) communications model for Open Systems Interconnection (OSI) - the application layer Medical software - Trends, Standards & Future Sreedhar Kodlahalli 7 Application 6 Presentation 5 Session 4 Transport 3 Network 1 Physical Function Communication

19. Medical software - Standard : IHE Definition A set of Actors cooperating through T ransaction s to perform a specific task Examples Scheduled WorkFlow (SWF) - Admit, order, schedule, acquire images, notify of completed steps Consistent Presentation of Images(CPI) - Hardcopy and softcopy grayscale presentation state Key Image Notes(KIN) - Flag significant images Describe the solution to a specific integration problem, and document the system roles (Actors), standards and design details Defines integration capabilities by coordinated implementation of communication standards; such as DICOM, HL7, W3C and security standards Standards harmonization approach Medical software - Trends, Standards & Future Sreedhar Kodlahalli HIS RIS PACS Modality HIS HL7 HL7 --- --- RIS HL7 HL7 HL7/DICOM --- PACS --- HL7/DICOM DICOM DICOM Modality --- DICOM DICOM DICOM

20. Medical software - Standard : IHE salient features Confirmation statement - Supported set of Integration Profiles, Actors, and Transactions IHE Integration Statements - Simple documents prepared and published by a vendor to list the IHE Profiles supported by a specific release of a specific product IHE Technical Frameworks - Detailed documents which specify the Integration Profiles and the associated actors (systems) and transactions IHE Connectathons - Annual events where equipment vendors bring products with IHE Profiles and test them with other vendors Medical software - Trends, Standards & Future Sreedhar Kodlahalli

21. Medical software - Standard : CCOW The CCOW standard provides a mechanism for applications to share information so that they appear to behave as a single system. This shared information is known as the context Patient context User context Encounter context Addresses following integration challenges Multiple disparate applications - Labs, meds, cardiology, scheduling, billing Users in need of easy access to data and tools - Physicians, nurses, therapists, administrators. Kiosk as well as personal workstations - Hospitals, clinics, offices, homes Context manager Medical software - Trends, Standards & Future Sreedhar Kodlahalli Context Manager CCOW Mapping Agent Annotation Agent CCOW

22. Medical software - Standard : CCOW salient features Subject hierarchy Capabilities Secure Subjects - Only applications with access privileges may set or get (e.g., User) Dependent Subjects - The value of a subject must be consistent with the value for another subject (e.g., Encounter depends on Patient) Custom Subjects - May be defined by healthcare providers and/or vendors, distinct from HL7’s standard subjects Annotation Subjects - Data that is in addition to a subject’s identity (e.g., a Certificate is an annotation for the User subject) Medical software - Trends, Standards & Future Sreedhar Kodlahalli User* Patient Encounter Observation Certificate* * secure subject identity subject annotation subject

23. Medical software - Development The plan - PMP/QMP Configuration management - Documentation & Protocol Quality assurance (SQA) - Project management User expérience design - Project risk management Product risk management - Groups & Roles Tools & 3rd party software validation - Charm handling Testing - Traceability The holy grail Risk analysis & mitigation Quality Traceability Audit trails The Mantra Documentation Reviews Testing Medical software - Trends, Standards & Future Sreedhar Kodlahalli

24. Medical software - Typical development challenges Consistent patient / user identification Patient safety / medical records safety Statutory medical records retention for longer periods Integration with multi-vendor systems (Modality/HIS/RIS/PACS) Integration with multi-vendor applications Patient medical history privacy issues (HIPAA) Stringent quality standards (FDA, TÜV) Multi-modality integration ER workflow Patient Information Reconciliation - Exception handling Example: Image acquisition completed for an unidentified patient Example: Same patient receiving service at a different location across the same health service provider Medical software - Trends, Standards & Future Sreedhar Kodlahalli

25. Medical software - Future trends Zero-admin deployment Smart clients, remote viewing, streaming On demand – Application, Image & Performance Night-hawk reading Remote/collaborated/expert-assisted diagnosis/therapy Distributed workflows Pre-fetch, parallel steps Distributed PACS Network Attached Storage (NAS) Storage Area Network (SAN) Data cloud Multi-modality workflow integration E.g. Multi-modality reader Consistent framework everywhere; modality, pre/post-processing, reporting stations… Diagnosis Therapy to Preventive analysis Interventional healthcare Multi-modality assisted full-bodied human physio-model construction & diagnosis Medical software - Trends, Standards & Future Sreedhar Kodlahalli

26. Medical software - Microsoft initiative MICROSOFT HEALTH Common User Interface (CUI)* Support the delivery of safe patient care by providing detailed guidance for the standardization of clinical application user interfaces *Ref: http://www.mscui.org/Introduction/PatientSafety.aspx Microsoft HealthVault Simple end-user controlled health records that can be shared with health service providers and insurance agencies Medical software - Trends, Standards & Future Sreedhar Kodlahalli

27. Medical software - Tools to play… for free! HL7 Browser, Simulator - http://nule.org/wp/?page_id=55 Integration engine - http://www.mirthproject.org DICOM/PACS DICOM toolkit - http://dicom.offis.de/dcmtk.php.en Viewer - http://dicom.online.fr http://www.k-pacs.net Archive & image manager - http://www.dcm4che.org/confluence/display/ee2/Home Medical software - Trends, Standards & Future Sreedhar Kodlahalli

28. Medical software - References DICOM - http://medical.nema.org HIPAA - http://www.hhs.gov/ocr/privacy/index.html HL7 - http://www.hl7.org IHE - http://www.ihe.net CCOW - http://www.hl7.org/special/Committees/ccow_sigvi.htm ISO 14971:2007 - http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=38193 ISO 13485:2003 - http://www.iso.org/iso/catalogue_detail?csnumber=36786 FDA : Medical devices - http://www.fda.gov/cdrh/index.html TÜV : Medical devices - http://www.tuv.com/in/en/medical_devices.html CFIA - http://www.inspection.gc.ca/english/toce.shtml JPAL - http://www.aapspharmaceutica.com/meetings/files/104/VanAuwelaerJapanesePharmaLawSunriseSession.pdf Medical software - Trends, Standards & Future Sreedhar Kodlahalli

29. Thank YOU Medical software - Trends, Standards & Future Sreedhar Kodlahalli SREEDHAR KODLAHALLI BANGALORE, INDIA [email_address] [email_address]