Presentation on theme: "Oct. 2nd 2012, San Francisco Opening the discussion … • Why is it so important to manage Risk in health IT solutions? • How can we optimally protect."— Presentation transcript:
1Oct. 2nd 2012, San FranciscoOpening 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?Dipl.-Ing. Oliver P. ChristCEO Prosystem AG / Prosystem USA LLC13
2The 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.
3The CompanyOur 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 countriesapp. 30% of the annual turnover outside Europe (North America / Asia)all services from one source
4The Company PROSYSTEM FORUM On-Site Trainings and Workshops , Seminars in the USSoftware Development, Verification, and ValidationOn-Site Trainings and Workshops , Seminars
5Source: Julian Goldman Demanding needs of General Hospitals for a Safe & Effective Use of Medical Devices and Health SoftwareUser isn’t aware data transfer is reliant on so many other components and systemsSource: Julian Goldman
7IOM Report a “Game Changer”? American Institute of Medicine (IOM) Report, Published late 2011, 220 pagesKey findings:Health IT may lead to safer care and/or introduce new safety risksSafety is a characteristic of a sociotechnical system that includes people, process, environment, organization and technologySystem-level failures occur almost always because of unforeseen combinations of component failuresRecommendations:Health care accrediting organizations should adopt criteria relating to EHR safety.All health IT vendors should be required to publicly register and list their productsHealth IT vendors should be required to adopt quality and risk management processesReporting of health IT– related adverse events should be mandatory for vendors and voluntary and confidential for users.7
8Industry is using Risk Management for Medical Devices
9Focus 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:FunctionalInputsFunctionalOutputsMedical BenefitMedicalDeviceSo How does Risk Management focus on Patients?The Intended Use of a medical device can be depicted using an idealized functional input/output diagram as follows:The User or Operator delivers Functional Inputs to the medical deviceAnd The medical device delivers Functional Outputs to the patientAfter some time, this results in medical benefit to the patient.The medical device including Functional Inputs and Functional Outputs is known as the “engineering World”The effect of these functional outputs on the patient, including medical benefit, is known as the “clinical world”TimePatientPatientUser (Operator)
10Industry is using Safety Standards for Medical Devices
11Electrical Safety: IEC 60601-1 (3rd edition) In an environment of 1,5 m around an (accommodated) Patient …… increased requirements for Medical Electrical Equipment do apply including their connection to (medical) IT networks.
12IEC 60601-1/A1 - FDIS (verteilt als 62A/805/FDIS; vom 27.4.2012) PEMS = Programmable Electrical Medical SystemsIEC /A1 - FDIS (verteilt als 62A/805/FDIS; vom )PEMS intended to be connected to an IT-NetworkIf 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 SAFETYand ESSENTIAL PERFORMANCE (see also Clause H.6 and IEC :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.Compliance is checked by inspection of the instructions.
13IEC 60601-1/A1 - FDIS (verteilt als 62A/805/FDIS; vom 27.4.2012) (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 provides guidance for the RESPONSIBLE ORGANIZATION to address these risks.Compliance is checked by inspection of the accompanying documents.
15Scope and Key Properties of IEC 80001-1: 2010 “ This standard defines roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to addressSAFETY,EFFECTIVENESSData & system Security (the KEY PROPERTIES), …
16The „Medical IT-Network“ (protection goal of IEC 80001-1) Originally separate Medical Devices get connected via an (unsafe & unsecure) IT-Network of the Responsible OrganizationOut of this „general“ IT-Network emerge a new„Medical IT-Network“The Issues areHeavily 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 DevicesIT-Networks are supposed to „run“ 24/7
17Risk-Management Planning for each Key Propery Definition for each Medical IT-Network (separately)Key Properties for Risk-Management are:Safetyfor Patient, User/Operator und Third PartiesEffectivenessfor intended workflows supported by the IT-Network ability to produce the intended result for the patient and the Responsible OrganizationData- & System Securityreasonable protection from degradation of confidentiality, integrity and availability (of information assets)
19Important roles and responsibilities in IEC 80001-1 Responsible OrganizationreportsassignsTop ManagementRisk-Managerprovide InformationMedical Devices ManufacturerOthers
20The structure of the IEC 80001-1 series Part 1: Roles, Responsibilities and ActivitiesIEC YTechnical ReportsIEC X References to other IT Standards / SpecISO/IEC :2005 IEC 62304:2006 IEEE ff HL7, DICOMY = 1: Step-by Step RM Y = 2: Security Y = 3: Wireless Y = 4: HDO Guidance
21Up-date on IEC 80001-1 activities On July 19, three new Technical Reports has been published:IEC TR Ed 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 TR Ed 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 TR Ed Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks