Medical software - Trends, Standards & Future

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


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


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


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


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


Medical software Medical software - Systems & information flow- Systems & information flow

Medicare Provider Inventory

Admission/Discharge/Transfer

RIS

PACS Workstation

HIS

Modality

Master Patient Index


Medical software Medical software - Typical Workflow- Typical Workflow


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


Medical software Medical software - IHE Radiology Workflow- IHE Radiology Workflow

*Picture Ref: IHE – Radiology Workflow – Present & Future Extensions EuroPACS 2002 Conference – Oulu / Finland

*


Medical software Medical software - Systems / Roles- Systems / Roles

To ensure Data availability Consistency


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


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”


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


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


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)


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


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


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


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


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


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


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


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


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


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


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


Thank YOUThank YOU


SREEDHAR KODLAHALLIBANGALORE, INDIA

[email protected]@GMAIL.COM

Technology

Medical software - Trends, Standards & Future