AAMI TIR 97 pdf free download

AAMI TIR 97 pdf free download.Principles for medical device security- Postmarket risk management for device manufacturers.
3 Postmarket considerations for security policies and security program administration 3.1 Medical device security policy AAMI T1R57:2016 provides guidance on developing a medical device security policy in Subclause 3.2, Management responsibilities. The medical device security policy should define management’s intent to secure the organization’s medical devices throughout their lifecycle. The policy should address postmarket regulatory requirements and be supported by standards, procedures, work instructions, and other artifacts that address security risk management, threat event handling, incident handling, coordinated vulnerability disclosure, and security education and training. In addition, the policy should facilitate consistent and effective external communications, as well as allow for monitoring and improvement of the processes required by the policy. Postmarket information in the policy should include, but not be limited to, threat intelligence, patch and vulnerability management, threat event and incident handling, security risk assessment, and third-party risk management The policy should also include requirements for security maintenance across the entire device life-cycle. Annex A provides a non-exhaustive list of sample statements that can be incorporated in a manufacturer’s medical device security policy. 3.2 Coordinated vulnerability disclosure Manufacturers should develop a coordinated vulnerability disclosure process to provide security researchers and others with a means to communicate device vulnerabilities to appropriate parties, including regulatory authorities. Subclause 61.2 and Annex C provide additional information about establishing a coordinated vulnerability disclosure process. NOTE The customer communication channel for handling complaints can typically be used for handling reports of poterial vulnerabilities with minor modifications and appropriate trairing.3.4 Communication of security capabilities
Potential customers often send inquiries to manufacturers requesting the security capabilities of products under consideration. The manufacturer should establish and maintain a process for providing potential, and existing, customers with current and accurate security capability documentation. The format and content of this documentation should be consistent. An accurate software bill of materials (SBOM) is a key component for creating a product security risk assessment, performing technical security testing, monitoring of threats and vulnerabilities, and responding effectively to threat events. An SBOM also supports HDOs in establishing an inventory of medical devices, including software.
NOTE A Security Bill of Materials (CBOM) would indude hardware sub-components in addition to the SBOM. In this document we will continue to use the term SBOM because it is well understood.
A common way to communicate the security capabilities of medical devices is the Manufacturer Disclosure Statement for Medical Device Security (MDS2) form [6]. The value of the MDS2 form depends on the level of detail provided in the unotes sections for each security capability. In many cases, customers request detailed information about security capabilities of medical devices in their own format. The manufacturer should be prepared to respond to these requests in a timely manner. Some requests could necessitate the development of contractual provisions to protect the intellectual property of the manufacturer.
To facilitate timely responses to detailed customer inquiries, manufacturers should describe the security capabilities of a device in a standardized format, in a template with consistent language between product teams, during the product generation/creation process. This information supports the preparation of MDS2 forms for the product and can form the basis of standard responses to customer inquiries. MDS2 forms should be made available to customers upon request, and updated forms should be released whenever security capabilities are modified due to new product or version releases.AAMI TIR97 pdf download.