PD IEC/TR 80001-2-8:2016

What is PD IEC/TR 80001-2-8 – Application guidance on security capabilities and risk management for IT networks about ?

PD IEC/TR 80001-2-8 is an international standard that focuses guidance on standards for establishing the security capabilities and applications of risk management for IT networks incorporating medical devices. 

PD IEC/TR 80001-2-8 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 require the disclosure of security-related capabilities and risks. 

The purpose of PD IEC/TR 80001-2-8 is to identify security controls, which exist in these particular security standards, that apply to each of the security capabilities. 

PD IEC/TR 80001-2-8 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. 

Who is PD IEC/TR 80001-2-8 - Application guidance on security capabilities and risk management for IT networks for ?

PD IEC/TR 80001-2-8 on standards for establishing the security capabilities and applications of risk management for IT networks is useful for: 

• Medical device manufacturers 
• Health delivery organizations
• Network engineers 
• IT support engineers 
• Consultants and quality assurance services 

Why should you use PD IEC/TR 80001-2-8 - Application guidance on security capabilities and risk management for IT networks ?

The selection of security capabilities and security controls is based on the risk evaluation and risk tolerance with consideration for the protection of patient safety, life and health. The operational environment, network structure and local factors should determine which security capabilities are required and which security controls assist in establishing that security capability. 

The application of risk management to IT networks incorporating medical devices provides the roles, responsibilities, and activities necessary for risk management. PD IEC/TR 80001-2-8 provides guidance for the establishment of each of the security capabilities. 

PD IEC/TR 80001-2-8 provides users guidance on an informative set of common, descriptive security capabilities intended to be the starting point for a security-centric discussion between the vendor and purchaser or among a larger group of stakeholders involved in a medical device it-network project. 

PD IEC/TR 80001-2-8 identifies security controls from key security standards which aim to provide guidance to a responsible organization when adapting the framework. 

In addition to providing a basis for discussing risk and respective roles and responsibilities toward risk management, PD IEC/TR 80001-2-8 also provides users with: 

• Health delivery organizations (HDOs) with a catalogue of management, operational and administrative security controls to maintain the effectiveness of a security capability for a medical device on a medical device it-network 

• Medical device manufacturers (MDMs) with a catalogue of technical security controls for the establishment of each of the 19 security capabilities 

Adoption of PD IEC/TR 80001-2-8 enables users to establish security capabilities in medical devices, ensuring the security of data, operability, and performance in medical applications.