workshop on high confidence medical device software and systems (hcmdss) research & roadmap june...
TRANSCRIPT
Workshop on High Confidence Medical Device Software and
Systems (HCMDSS)Research & Roadmap
June 2-3, 2005 Philadelphia, PA.
Manufacturer/Care-Giver PerspectiveDavid R. Jones
Philips Medical Systems
2David R. JonesPhilips Medical Systems
High Confidence Medical Device SW & Systems Issues & Challenges
• SW development/verification/validation practices that drive predictable results
• The convergence of Information Technology & Biomedical Engineering
• The real-time patient monitoring and diagnosis continuum
• Security• SW based predictive medicine
3David R. JonesPhilips Medical Systems
Software Development & Validation Practices That Drive
Predictable ResultsCMMI(a) LevelHeroes/Initial: Level 1
Optimizing: Level 5
Defect Predictability
10-20 Defects/KLOCIn delivered code
0.05 Defects/KLOC In delivered code
Schedule Predictability
Software releaseschedules slip
up to 100%
Software releaseson schedule 95% of
the time
Product Predictability
Several key features deferred to the next
release
Product performance delivered meets the
Systems Requirement Specification
Ref: Real-world benchmarks for PSP, Carnegie Mellon University Software Engineering Institute 1999
(a) : Capability Maturity Model Integrated
4David R. JonesPhilips Medical Systems
Software Development & Validation Practices That Drive Predictable Results –
and Map To FDA Requirements21 CFR 820
Subparts
Sub-Part Description
CMMI Process Areas
CMMI
Maturity Levels
B Quality System Requirements Organizational Training Organizational Process Definition
Organizational Process Focus Integrated Project Management
3 3 3 3
C Design Controls Requirements Management Requirements Development
Technical Solution Product Integration
Verification& Validation Risk Management
2 3 3 3 3 3
D Document Controls Configuration Management 2 E Purchasing Controls Supplier Agreement Management
Integrated Supplier Management 2 3
F Identification & Traceability Project Monitoring and Control Measurement & Analysis
2 2
G Production & Process Controls Organizational Process Focus Organizational Process Definition
Organizational Process Performance Organizational Innovation /Deployment Process & Product Quality Assurance
3 3 4 5 2
H Acceptance Activities Supplier Agreement Management Integrated Supplier Management
Verification& Validation
2 2 3
I Non-conforming Products Process & Product Quality Assurance Decision Analysis & Resolution
2 3
J Corrective & Preventive Action Measurement & Analysis Decision Analysis & Resolution Causal Analysis & Resolution
2 3 5
K Labeling & Packaging Control Process & Product Quality Assurance 2 L Handling, Storage, Distribution & Installation Process & Product Quality Assurance 2 M Records Configuration Management 2 N Servicing Technical solution 3 O Statistical Techniques Quantitative Project Management
Measurement & Analysis 4 2
Ref: Best Practices in Software Design for Medical Devices March, 2004. Presentation by D.R. Jones, T. Shah.
5David R. JonesPhilips Medical Systems
IT and Biomedical
Our devices are life-critical!
Our information systems are
mission-critical!
6David R. JonesPhilips Medical Systems
IT and Biomedical
• Different Perspective
• Life-critical vs.mission-critical
• Medical devices vs. Information Systems
• The Biomed links medicine and technology
7David R. JonesPhilips Medical Systems
Convergence
• Medical Technology intertwined with IT• Move toward Electronic Medical Record
(EMR), Clinical Decision Support Systems (CDSS) requires information flow
• Devices are an integral part of information flow
• More regulations and protocol requirements (JCAHO, Leapfrog) drives data movement
• Desire to integrate data from real-time systems to achieve smart/predictive alarms
8David R. JonesPhilips Medical Systems
The Real Time Patient Monitoring And Diagnosis Continuum
Monitoring &Diagnostics
ofReal Time
InstrumentedPatients
Department/EnterpriseIT Systems
Data Capture& Storage
Closed loop feedback Driven by Interoperability &
Common Standards Requirements
Patient Monitoring Clinical Measurements
Observations Charting Quality Assurance Admit/Discharge/Transfer Staffing Very long-term data storage
9David R. JonesPhilips Medical Systems
Security: Today’s Environment
• Thousands of new vulnerabilities yearly• Weekly attacks on the rise• Viruses are quick – patch validation is relatively
slow• Hospitals are public places• Hospitals subject to privacy and security
regulations
10David R. JonesPhilips Medical Systems
Security Risk = Vulnerabilities x Threats
Mitigation• Vulnerabilities– Flaws or weaknesses in system design,
implementation, operation, or management
• Threats– Malicious inside or outside intruders,
accidents• Mitigation
– Security measures
11David R. JonesPhilips Medical Systems
HIPAA Security Rule
• A regulation, not a standard• Goal: develop and maintain the security of all electronic
protected health information (PHI).• Hospitals must protect against “reasonably anticipated”
security threats/disclosure of info• Largely administrative, even for security• Some technical safeguards are recommended• Covered Entities are:
– Health Plans – Health Care Providers – Health Care Data Clearing Houses
• Heath care providers, therefore, ask Medical Device Manufacturers for features and assurances that help them comply
12David R. JonesPhilips Medical Systems
Shared Responsibility for Security
• Vendor role– Risk assess products
considering intended user environment
– Be sure hospital IT is involved early
– Validate patches for critical systems
– Understand customer security needs
• Customer role– Multi-layer strategy to
protect information• Policy, process,
technology • risk management, and
contingency planning– Firewalls or other
network devices are good practice
– Follow medical device vendor statements on patching
13David R. JonesPhilips Medical Systems
The Role of the FDAWith respect to security patching of the OS on
certain (regulated) products:
• The vendor must prove that software still is safe and effective in the presence of the patch
• Thorough testing under a quality system takes time and effort to prove this, depending on complexity
• The FDA requires that vendors have a quality system, and that vendors verify changes, including patches.
14David R. JonesPhilips Medical Systems
ScreeningDiagnosis &
StagingTreatment &Monitoring
Follow-up
Unspecificmarkers
POC imaging Mammography
Diagnosticimaging
Biopsies
Surgery Cath tab Radiation
therapy
Diagnosticimaging
Unspecificmarker
To
day
Developingmolecularsignature
Firstsymptoms
Progressingdisease
Progress of Disease
Current Diagnosis and Treatment Process
Ref: MEDICAMUNDI 47/1 April 2003
15David R. JonesPhilips Medical Systems
Software Based Predictive Medicine
ScreeningDiagnosis &
StagingTreatment &Monitoring Follow-up
ScreeningDiagnosis &
StagingFollow-up
Treatment &Monitoring
Unspecificmarkers
POC imaging Mammography
Diagnosticimaging
Biopsies
Surgery Cath tab Radiation
therapy
Diagnosticimaging
Unspecificmarker
Specificmarkers (MDx)
Molecular imaging Quantitative
imaging Whole-body
imaging Comp. Aided
Diagnostics.
Min. invasivesurgery
Local/targeted drugdelivery
Drug tracing Tissue analysis
(MDx)
Non-invasive andquantitativeimaging
Molecular imaging Molecular
diagnostics (MDx)
To
day
To
mo
rro
w
Geneticpredisposition
DNA mutations
Developingmolecularsignature
Firstsymptoms
Progressingdisease
Progress of Disease
Ref: MEDICAMUNDI 47/1 April 2003
