Medical softwareMedical softwareTrends, Standards & Future
SREEDHAR KODLAHALLIBANGALORE, INDIA
10 OCTOBER 2011
A sand-box of all things Medical…
Medical software Medical software - Medical Device : Definition- 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.
2Medical software - Trends, Standards & Future Sreedhar Kodlahalli
Medical software Medical software - Lexicon- 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
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Medical software Medical software - Healthcare segments- Healthcare segments
Imaging (e.g., CT, MRI, US …)
Information systems (e.g., clinical, operational, financial)
Non-invasive therapyInvasive therapyMedical implants (e.g., heart valve)
Home/Personal carePharma/LabsReferring physician, billing, insuranceMedical transcriptions
4Medical software - Trends, Standards & Future Sreedhar Kodlahalli
Medical software Medical software - Traditional medical ‘ologies’- 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
5Medical software - Trends, Standards & Future Sreedhar Kodlahalli
Medical software Medical software - Current trends- Current trends
Workflow enabledEstablishes a seamless flow of information that
supports efficient patient care workflow in a typical imaging encounter maintaining the consistency of patient information
Context awareProcess 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 basedAppropriate selection of tools and processes based on
the selected data and the role executing the data
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Medical software Medical software - Statutory regulations/ - Statutory regulations/
CertificationsCertificationsMedical standards
ISO 14971 - Application of risk management to medical devices
ISO 13485 - Quality management standard for medical devices
HardwareCE 0413 marking
Regulatory approvalsFDA - Food & Drug Administration, USA
TÜV - Technische Überwachungs-Verein, European Union
CFIA - Canadian Food Inspection Agency, Canada
JPAL - Japanese Pharmaceutical Affairs Law, Japan
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Medical software Medical software - Systems & information flow- Systems & information flow
Medicare Provider Inventory
Admission/Discharge/Transfer
RIS
PACS Workstation
HIS
Modality
Master Patient Index
8Medical software - Trends, Standards & Future Sreedhar Kodlahalli
Medical software Medical software - Typical Workflow- Typical Workflow
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Medical software Medical software - Workflow steps- Workflow steps
RegistrationOrderScheduling
Image acquisitionPre-processing / QC Image archivalPost-processing / measurements / QCReading / reporting / billing
Referring physician Therapy / out-patient care / follow-up
10Medical software - Trends, Standards & Future Sreedhar Kodlahalli
Medical software Medical software - IHE Radiology Workflow- IHE Radiology Workflow
*Picture Ref: IHE – Radiology Workflow – Present & Future Extensions EuroPACS 2002 Conference – Oulu / Finland
*
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Medical software Medical software - Systems / Roles- Systems / Roles
To ensure Data availability Consistency
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Medical software Medical software - Worklists- 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
13Medical software - Trends, Standards & Future Sreedhar Kodlahalli
Medical software Medical software - Industry inter-operability - Industry inter-operability
standardsstandardsHIPAA - 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”
14Medical software - Trends, Standards & Future Sreedhar Kodlahalli
Medical software Medical software - Standard : HIPAA - Standard : HIPAA Privacy & Privacy &
SecuritySecurity 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
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Medical software Medical software - Standard : DICOM- Standard : DICOM
HierarchyPatient
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
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Medical software Medical software - Standard : DICOM salient - Standard : DICOM salient
featuresfeatures 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)
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Medical software Medical software - Standard : HL7- 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
7 Application6 Presentation5 Session4 Transport3 Network
1 Physical
Function
Communication
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Medical software Medical software - Standard : IHE- Standard : IHE
Definition A set of Actors cooperating through Transactions 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 approachHIS RIS PACS Modality
HIS HL7 HL7 --- ---
RIS HL7 HL7 HL7/DICOM ---
PACS --- HL7/DICOM DICOM DICOM
Modality --- DICOM DICOM DICOM
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Medical software Medical software - Standard : IHE salient features- 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
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Medical software Medical software - Standard : CCOW- 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
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Context Manager
CCOW
Mapping Agent Annotation Agent
CCOW
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 Medical software - Standard : CCOW salient - Standard : CCOW salient
featuresfeatures Subject hierarchy
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User* Patient
Encounter
Observation
Certificate*
* secure subject
identity subject
annotation subject
Medical software Medical software - Development- 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
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Medical software Medical software - Typical development - Typical development
challengeschallenges 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
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Medical software Medical software - Future trends- 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
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Medical software Medical software - Microsoft initiative- 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
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Medical software Medical software - Tools to play… - Tools to play… for free!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
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Medical software Medical software - References- 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
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Thank YOUThank YOU
29Medical software - Trends, Standards & Future Sreedhar Kodlahalli
SREEDHAR KODLAHALLIBANGALORE, INDIA
[email protected]@GMAIL.COM