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 the privacy and integrity of patients' records? • How can hospitals and medical device manufacturers benefit from latest safety standards? Dipl.-Ing. Oliver P. Christ CEO Prosystem AG / Prosystem USA LLC 13 oliver.christ@prosystem-ag.com

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. info@prosystem-ag.com

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 info@prosystem-ag.com

The Company PROSYSTEM FORUM On-Site Trainings and Workshops , Seminars in the US Software Development, Verification, and Validation On-Site Trainings and Workshops , Seminars info@prosystem-ag.com

Source: Julian Goldman Demanding needs of General Hospitals for a Safe & Effective Use of Medical Devices and Health Software User isn’t aware data transfer is reliant on so many other components and systems Source: Julian Goldman

Requirements from accreditors? 6

IOM Report a “Game Changer”? American Institute of Medicine (IOM) Report, Published late 2011, 220 pages 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. 7

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: Functional Inputs Functional Outputs Medical Benefit Medical Device So 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 device And The medical device delivers Functional Outputs to the patient After 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” Time Patient Patient User (Operator)

Industry is using Safety Standards for Medical Devices info@prosystem-ag.com

Electrical 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. oliver.christ@prosystem-ag.com

IEC 60601-1/A1 - FDIS (verteilt als 62A/805/FDIS; vom 27.4.2012) PEMS = Programmable Electrical Medical Systems IEC 60601-1/A1 - FDIS (verteilt als 62A/805/FDIS; vom 27.4.2012) 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. Compliance is checked by inspection of the instructions. oliver.christ@prosystem-ag.com

IEC 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 80001-1 provides guidance for the RESPONSIBLE ORGANIZATION to address these risks. Compliance is checked by inspection of the accompanying documents. oliver.christ@prosystem-ag.com

oliver.christ@prosystem-ag.com

Scope 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 address SAFETY, EFFECTIVENESS Data & system Security (the KEY PROPERTIES), … oliver.christ@prosystem-ag.com

The „Medical IT-Network“ (protection goal of IEC 80001-1) 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 info@prosystem-ag.com

Risk-Management Planning for each Key Propery 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) oliver.christ@prosystem-ag.com

Requirements to: oliver.christ@prosystem-ag.com

Important roles and responsibilities in IEC 80001-1 Responsible Organization reports assigns Top Management Risk-Manager provide Information Medical Devices Manufacturer Others oliver.christ@prosystem-ag.com

The structure of the IEC 80001-1 series Part 1: Roles, Responsibilities and Activities IEC 80001-2-Y Technical Reports IEC 80001-X References to other IT Standards / Spec ISO/IEC 20000-1:2005 IEC 62304:2006 IEEE 11073-ff HL7, DICOM Y = 1: Step-by Step RM Y = 2: Security Y = 3: Wireless Y = 4: HDO Guidance oliver.christ@prosystem-ag.com

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  info@prosystem-ag.com