Dipl.-Ing. Oliver P. Christ
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Beim Strohhause 27 20097 Hamburg phone +49 (0)40 47 10 36 14 fax +49 (0)40 47 10 36 20 web www.prosystem-ag.com [email protected] Dipl.-Ing. Oliver P. Christ CEO Prosystem AG / Prosystem USA LLC 1 3 Opening the discussion … • Why is it so important to manage Risk in health IT solutions? • How can we optimally protect the privacy and integrity of patients' records? • How can hospitals and medical device manufacturers benefit from latest safety standards? Oct. 2 nd 2012, San Francisco [email protected]
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Oct . 2 nd 2012, San Francisco . - PowerPoint PPT Presentation
Transcript of Dipl.-Ing. Oliver P. Christ
Beim Strohhause 2720097 Hamburg
phone +49 (0)40 47 10 36 14 fax +49 (0)40 47 10 36
20web www.prosystem-ag.com
Dipl.-Ing. Oliver P. Christ CEO Prosystem AG / Prosystem USA LLC
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Opening the discussion …
• Why is it so important to manage Risk in health IT solutions?• How can we optimally protect the privacy and integrity of patients' records?• How can hospitals and medical device manufacturers benefit from latest safety standards?
Oct. 2nd 2012, San Francisco
The CompanyPROSYSTEM AG is an international consulting company providing comprehensive services for the medical device industry.
The company was established in 1999 by Prof. Dr. Jürgen Stettin and his partner Oliver P. Christ. Together with its subsidiary PROSYSTEM USA LLC, located in San Diego, CA/USA, PROSYSTEM AG services clients in more than 25 countries.
The Company
Our clients are manufacturers and developers of medical devices, suppliers, operators, the pharmaceutical industry, universities, and Notified Bodies.
Being an active member of different standardization groups, PROSYSTEM can provide its clients with detailed background information about the origin, implementation and future development of respective applicable standards.
Business activities include analysis, training, consulting services, and the realization of projects:
• more than 150 clients in 25 countries• app. 30% of the annual turnover outside Europe (North America / Asia)• all services from one source
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PROSYSTEM FORUM
On-Site Trainings and Workshops , Seminars
in the US
Software Development, Verification, and
Validation
On-Site Trainings and Workshops , Seminars
The Company
Demanding needs of General Hospitals for a Safe & Effective Use of Medical Devices and Health Software
Monitoring Network
Care Unit 1
Care Unit 2...
Patientmonitor
Enterprise Network
Ventilator
Internet
OEM Vendor
Applications:Admissions,
Bed Management, Interface Engines...
PC
Bed X-RefTable
OEMGateway
Internet
OEMEmployee
SecureRemoteAccess
Router
Patient Room
ADT
Interfaces and other components:
Medical Equipment, eMAR, Allergies,
Labs, Problem List...
EMRApplication and
InterfaceServers (virtual)
Clinician
Source: Julian Goldman
Requirements from accreditors?
Key findings: Health IT may lead to safer care and/or introduce new
safety risks Safety is a characteristic of a sociotechnical system
that includes people, process, environment, organization and technology
System-level failures occur almost always because of unforeseen combinations of component failures
Recommendations: Health care accrediting organizations should adopt
criteria relating to EHR safety. All health IT vendors should be required to publicly
register and list their products Health IT vendors should be required to adopt quality
and risk management processes Reporting of health IT– related adverse events should
be mandatory for vendors and voluntary and confidential for users.
IOM Report a “Game Changer”?American Institute of Medicine (IOM) Report, Published late 2011, 220 pages
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Industry is using Risk Management for Medical Devices
Focus on Patient Safety
How does Risk Management focus on Patients?
The Intended Use of a medical device can be depicted using an idealized functional input/output diagram:
MedicalDevice
Patient
User (Operator)
FunctionalInputs
FunctionalOutputs
Patient
Medical Benefit
Time
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Electrical Safety: IEC 60601-1 (3rd edition)
In an environment of 1,5 maround an (accommodated) Patient …
… increased requirements for Medical Electrical Equipment do apply including their connection to (medical) IT networks.
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14.13. PEMS intended to be connected to an IT-Network If the PEMS is intended to be incorporated into an IT-NETWORK that is not validated by
the PEMS MANUFACTURER, the MANUFACTURER shall make available instructions for implementing such connection including the following:
a) the purpose of the PEMS’s connection to an IT-NETWORK;
b) the required characteristics of the IT-NETWORK incorporating the PEMS;
c) the required configuration of the IT-NETWORK incorporating the PEMS;
d) the technical specifications of the network connection of the PEMS including security specifications;
•
e) the intended information flow between the PEMS the IT-NETWORK and other devices on the IT-NETWORK, and the intended routing through the IT-NETWORK; and NOTE 1 This can include aspects of effectiveness and data and system security as related to BASIC SAFETY
and ESSENTIAL PERFORMANCE (see also Clause H.6 and IEC 80001-1:2010).
f) a list of the HAZARDOUS SITUATIONS resulting from a failure of the IT-NETWORK to provide the characteristics required to meet the purpose of the PEMS connection to the IT-NETWORK.
IEC 60601-1/A1 - FDIS (verteilt als 62A/805/FDIS; vom 27.4.2012)
Compliance is checked by inspection of the instructions.
PEMS = Programmable Electrical Medical Systems
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(continue)
In the ACCOMPANYING DOCUMENTS the MANUFACTURER shall instruct the RESPONSIBLE ORGANISATION that:
– connection of the PEMS to an IT-NETWORK that includes other equipment could result in previously unidentified RISKS to PATIENT, OPERATORS or third parties;– the RESPONSIBLE ORGANISATION should identify, analyze, evaluate and control these RISKS;– subsequent changes to the IT-NETWORK could introduce new RISKS and require additional analysis; and– changes to the IT-NETWORK include:
• changes in the IT-network configuration;• connection of additional items to the IT-NETWORK;• disconnecting items from the IT-NETWORK;• update of equipment connected to the IT-NETWORK;• upgrade of equipment connected to the IT-NETWORK.
NOTE 3: IEC 80001-1 provides guidance for the RESPONSIBLE ORGANIZATION to address these RISKS.
IEC 60601-1/A1 - FDIS (verteilt als 62A/805/FDIS; vom 27.4.2012)
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
Scope and Key Properties of IEC 80001-1: 2010
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“ This standard defines roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address
SAFETY, EFFECTIVENESS DATA & SYSTEM SECURITY
(the KEY PROPERTIES), …
• Originally separate Medical Devices get connected via an (unsafe & unsecure) IT-Network of the Responsible Organization
• Out of this „general“ IT-Network emerge a new
„Medical IT-Network“
The Issues are• Heavily regulated „safe Medical Devices“ get connected with
„off-the-shelf IT-Hardware“ • There is no clear Responsibilities established (MT vs. IT)• Disturbances/Overload at an IT-Network could compromise
the safety of Medical Devices• IT-Networks are supposed to „run“ 24/7
The „Medical IT-Network“ (protection goal of IEC 80001-1)
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• Definition for each Medical IT-Network (separately)
• Key Properties for Risk-Management are:
Safety for Patient, User/Operator und Third Parties
Effectiveness for intended workflows supported by the IT-Network
ability to produce the intended result for the PATIENT and the RESPONSIBLE ORGANIZATION
Data- & System Security reasonable protection from degradation of confidentiality,
integrity and availability (of information assets)
Risk-Management Planning for each Key Propery
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Important roles and responsibilities in IEC 80001-1
Top Management
Risk-Manager
Medical Devices ManufacturerOthers
reportsassigns
provide Information
Responsible Organization
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The structure of the IEC 80001-1 series
IEC 80001-1Part 1: Roles,
Responsibilities and Activities
IEC 80001-XReferences to otherIT Standards / Spec
IEC 80001-2-YTechnicalReports
ISO/IEC 20000-1:2005IEC 62304:2006IEEE 11073-ffHL7, DICOM
Y = 1: Step-by Step RMY = 2: SecurityY = 3: WirelessY = 4: HDO Guidance
Up-date on IEC 80001-1 activities
On July 19, 2012 three new Technical Reports has been published:
IEC 80001-2-1 TR Ed.1.0 - Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
IEC 80001-2-2 TR Ed.1.0 - Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC 80001-2-3 TR Ed.1.0 - Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
