AAMI/IEC TR80001-2-8: 2016 pdf download – Application of risk management for IT networks incorporating medical devices- Part 2-8: Application guidance- Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2.
1 Scope This part of IEC 80001 , which is a Technical Report, provides guidance to Health Delivery Organizations (HDOs) and MEDICAL DEVICE manufacturers (MDMs) for the application of the framework outlined in IEC TR 80001 -2-2. Managing the RISK in connecting MEDICAL DEVICES to IT- NETWORKS requires the disclosure of security-related capabilities and RISKS . IEC TR 80001 -2-2 presents a framework for this disclosure and the security dialog that surrounds the IEC 80001 -1 RISK MANAGEMENT of IT- NETWORKS . IEC TR 80001 -2-2 presents an informative set of common, descriptive security-related capabilities that are useful in terms of gaining an understanding of user needs. This report addresses each of the SECURITY CAPABILITIES and identifies SECURITY CONTROLS for consideration by HDOs and MDMs during RISK MANAGEMENT activities, supplier selection, device selection, device implementation, operation etc. It is not intended that the security standards referenced herein are exhaustive of all useful standards; rather, the purpose of this technical report is to identify SECURITY CONTROLS , which exist in these particular security standards (listed in the introduction of this technical report), that apply to each of the SECURITY CAPABILITIES . This report provides guidance to HDOs and MDMs for the selection and implementation of management, operational, administrative and technical SECURITY CONTROLS to protect the confidentiality, integrity, availability and accountability of data and systems during development, operation and disposal. All 1 9 SECURITY CAPABILITIES are not required in every case and the identified SECURITY CAPABILITIES included in this report should not be considered exhaustive in nature.
3.2 EFFECTIVENESS ability to produce the intended result for the patient and the RESPONSIBLE ORGANIZATION [SOURCE: IEC 80001 -1 :201 0, 2.6] 3.3 HARM physical injury or damage to the health of people, or damage to property or the environment, or reduction in EFFECTIVENESS , or breach of DATA AND SYSTEMS SECURITY [SOURCE: IEC 80001 -1 :201 0, 2.8] 3.4 HAZARD potential source of HARM [SOURCE: IEC 80001 -1 :201 0, 2.9] 3.5 HEALTH DATA PRIVATE DATA that indicates physical or mental health Note 1 to entry: This term generically defines PRIVATE DATA and it subset, HEALTH DATA , within this report to permit users of this report to adapt it easily to different privacy compliance laws and regulations. For example, in Europe, the requirements might be taken and references changed to “Personal Data” and “Sensitive Data”; in the USA, HEALTH DATA might be changed to “Protected Health Information (PHI)” while making adjustments to text as necessary. 3.6 INTENDED USE INTENDED PURPOSE use for which a product, PROCESS or service is intended according to the specifications, instructions and information provided by the manufacturer [SOURCE: IEC 80001 -1 :201 0, 2.1 0] 3.7 IT- NETWORK INFORMATION TECHNOLOGY NETWORK system or systems composed of communicating nodes and transmission links to provide physically linked or wireless transmission between two or more specified communication nodes [SOURCE: IEC 80001 -1 :201 0, 2.1 2] 3.8 MEDICAL DEVICE means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: – diagnosis, prevention, monitoring, treatment or alleviation of disease, – diagnosis, monitoring, treatment, alleviation of or compensation for an injury, – investigation, replacement, modification, or support of the anatomy or of a physiological PROCESS , – supporting or sustaining life,– control of conception, – disinfection of MEDICAL DEVICES , – providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. Note 1 to entry: The definition of a device for in vitro examination includes, for example, reagents, calibrators, sample collection and storage devices, control materials, and related instruments or apparatus. The information provided by such an in vitro diagnostic device may be for diagnostic, monitoring or compatibility purposes. In some jurisdictions, some in vitro diagnostic devices, including reagents and the like, may be covered by separate regulations. Note 2 to entry: Products which may be considered to be MEDICAL DEVICES in some jurisdictions but for which there is not yet a harmonized approach, are: – aids for disabled/handicapped people; – devices for the treatment/diagnosis of diseases and injuries in animals; – accessories for MEDICAL DEVICES (see Note to entry 3); – disinfection substances; – devices incorporating animal and human tissues which may meet the requirements of the above definition but are subject to different controls. Note 3 to entry: Accessories intended specifically by manufacturers to be used together with a ‘parent’ MEDICAL DEVICE to enable that MEDICAL DEVICE to achieve its INTENDED PURPOSE should be subject to the same GHTF procedures as apply to the MEDICAL DEVICE itself. For example, an accessory will be classified as though it is a MEDICAL DEVICE in its own right. This may result in the accessory having a different classification than the ‘parent’ device.