Beim Strohhause Hamburg phone +49 (0) fax +49 (0) web Dipl.-Ing. Oliver P. Christ CEO Prosystem AG / Prosystem USA LLC 13 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
The Company PROSYSTEM 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. 2
The Company 3 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
4 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 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
8 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: Medical Device Medical Device Patient User (Operator) Functional Inputs Functional Outputs Patient Medical Benefit Time
10 Industry is using Safety Standards for Medical Devices
11 Electrical Safety: IEC (3 rd 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.
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 :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 /A1 - FDIS (verteilt als 62A/805/FDIS; vom ) Compliance is checked by inspection of the instructions. PEMS = Programmable Electrical Medical Systems
(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. 13 NOTE 3: IEC provides guidance for the RESPONSIBLE ORGANIZATION to address these RISKS. IEC /A1 - FDIS (verteilt als 62A/805/FDIS; vom ) Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
Scope and Key Properties of IEC : “ 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 )
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 R ESPONSIBLE O RGANIZATION Data- & System Security reasonable protection from degradation of confidentiality, integrity and availability (of information assets) Risk-Management Planning for each Key Propery 17
Requirements to: 18
Important roles and responsibilities in IEC Top Management Risk-Manager Medical Devices Manufacturer Others provide Information Responsible Organization
20 The structure of the IEC series IEC Part 1: Roles, Responsibilities and Activities IEC X References to other IT Standards / Spec IEC Y Technical Reports ISO/IEC :2005 IEC 62304:2006 IEEE ff HL7, DICOM Y = 1: Step-by Step RM Y = 2: Security Y = 3: Wireless Y = 4: HDO Guidance
Up-date on IEC activities On July 19, 2012 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 21