1 Overview

1.1 General

Many Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs) provide vital support for people living with chronic disease or experiencing a life-threatening medical event. Cybersecurity attacks on vulnerable devices may lead to the alteration of prescribed therapy (e.g., sleep apnoea breathing therapy, insulin therapy) or to information disclosure that results in insurance or identity fraud or in direct or indirect patient harm. Companies subject to a successful cybersecurity attack may suffer financial harm and a negative reputation.

Manufacturers of regulated PHDs/PoCDs are required to address cybersecurity vulnerabilities through a detailed risk analysis of use cases specific to the device. Of the various approaches to vulnerability assessment, some are not repeatable, scalable, systematic, and auditable. Both manufacturers and regulatory bodies may benefit from a common approach to vulnerability assessment based on threat modeling capable of analyzing PHDs/PoCDs across domains and described in a trusted open consensus standard. Likewise, patients, providers, and payers benefit from consistent and sufficient information provided in PHD/PoCD labeling.

This standard is based on the PHD Cybersecurity Standards Roadmap findings (IEEE white paper [B4]) and presents a repeatable, scalable, systematic, and auditable approach to vulnerability assessment.2 While a specific approach is provided, any comparable approach is appropriate and will be compatible with the mitigations found in IEEE Std 11073‑40102™ [B3]. In Figure 1, this standard is depicted by the top row, and IEEE Std 11073‑40102 is depicted by the bottom row.

Figure 1 — Vulnerability assessment workflow

1.2 Scope

Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The process part of cybersecurity is risk analysis of use cases specific to a PHD/PoCD.

For PHDs/PoCDs, this standard defines an iterative, systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and estimation of risk. This iterative vulnerability assessment uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk.

1.3 Purpose

The purpose of this document is to define a common approach to cybersecurity assessment in PHDs/PoCDs and define an iterative, systematic, scalable, and auditable vulnerability assessment appropriate for use in the design of PHDs/PoCDs.

1.4 Word usage

The word shall indicates mandatory requirements strictly to be followed in order to conform to the standard and from which no deviation is permitted (shall equals is required to).3,4

The word should indicates that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others; or that a certain course of action is preferred but not necessarily required (should equals is recommended that).

The word may is used to indicate a course of action permissible within the limits of the standard (may equals is permitted to).

The word can is used for statements of possibility and capability, whether material, physical, or causal (can equals is able to).

BS EN ISO/IEEE 11073-40101:2022

Health informatics. Device interoperability - Foundational. Cybersecurity. Processes for vulnerability assessment

Current

Published:

31 May 2022