MANAGED OPEN SOURCE MEDICAL DEVICES

摘要

This document discusses designing and managing medical devices that are equipped with software, including a variety of ways of managing the public interest in safety and effectiveness of medical devices that are preferably implemented with open-source software. In one general aspect, a method of updating a medical device is disclosed. The method includes storing a vendor certificate in the device, and receiving and storing a licensed prescriber certificate in the device. A signed request to update code in the medical device can then be received and this request can be authenticated with one of the certificates, and the code can be updated in the medical device with code from the authenticated update request.

主权项

1. A medical device, including:
a processor for running software code, a field-upgradable code storage medium for storing code to be run by the processor, a network interface to enable updates to the code in the a field-upgradable code storage medium, a secure element, including:
code digest code operative to calculate a mathematical digest of code including field upgradable code,key storage for holding multiple public key certificates, andverification code for verifying that the code digest has been signed by at least one key associated with the stored certificates prior to accepting an upgrade, and one or more medical transducers for interacting with the patient and responsive to the code in the code store.