Managing software distribution for regulatory compliance

• US 8,806,473 B2
• Filed: 08/02/2011
• Issued: 08/12/2014
• Est. Priority Date: 08/02/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Birtwhistle, Daniel P., Long, James R., Reinke, Robert E.
• Primary Examiner(s): Wong, Don
• Assistant Examiner(s): Rivera, Anibal
• Application Number:
  US13/195,884
• Publication Number:
  US 20130036414A1
• Time in Patent Office: 1,106 Days
• Field of Search: None
• US Class Current: 717/173
• CPC Class Codes: G06F 8/60 Software deployment
• CPC Class Codes: G06F 8/65 Updates security arrangements therefor G06F21/57

Abstract

A computer-implemented system is provided for distributing product updates to medical devices. An update interface residing on a distribution platform is configured to distribute product updates and maintain a log of such distributions in an audit database. A configuration device in data communication with the update interface registers itself with the update interface and downloads product updates from the update interface, such that the registration includes providing identifying information for the configuration device and a user of the configuration device. A medical device in data communication with the configuration device registers itself with the configuration device and downloads a particular product update from the configuration device, such that the configuration device creates a record of the particular product update and communications the record of the particular product update to the update interface. In this way, product updates distributed via the configuration device are recorded and tracked for regulatory purposes.

Claims

1. A computer-implemented system having a processor for distributing product updates, comprising:

an audit database operable to store distribution data for product updates;

an update interface is configured to distribute product updates and maintain the distribution data in the audit database;

a configuration device in data communication with the update interface to register itself with the update interface and operable to download product updates from the update interface; and

a medical device in data communication with the configuration device

to register itself with the configuration device and operable to download a particular product update from the configuration device, wherein the configuration device creates a record of the particular product update and communications the record of the particular product update, and the record

of the particular product update includes identifying information for a user of the configuration device, identifying information for the configuration device and identifying information for a user associated with the medical device, where the user of the configuration device differs from the user of the medical device.

2. The system of claim 1 wherein the update interface is configured to receive the record for the given product update from the configuration device and operable to update the audit database regarding the given product update.

3. The system of claim 1 wherein an entry for the given product update in the audit database includes identifying information for the configuration device, identifying information for a user of the configuration device and identifying information for the medical device.

4. The system of claim 1 wherein the configuration device queries the update interface for latest version of a given product update and the update interface communicates the latest version of the given product update to the configuration device in response to the query.

5. The system of claim 4 wherein the configuration device requests an upgrade for the given product update and the update interface downloads the given product update to the configuration device in response to the upgrade request.

6. The system of claim 5 wherein the configuration device verifies download of the given product update and communicates a confirmation message regarding the download to the update interface.

7. The system of claim 1 the configuration device operates to download the particular product update to the medical device while offline from the update interface.

8. The system of claim 7 wherein the configuration device creates a record of the particular product update in a transaction log, such that the record include identifying for the medical device.

9. A method for distributing product updates through an intermediary to end user medical devices, comprising:

registering a configuration application residing on an intermediary configuration device with an update interface of a distribution server, wherein the registration of the configuration device includes identifying information for a user of the configuration device and identifying information for the configuration device;

downloading a product update from the update interface to the configuration device;

registering a given medical device with the configuration application, wherein the registration includes identifying information for the given medical device and identifying information for a user associated with the medical device;

distributing the product update from the configuration device to the given medical device;

creating a record of the product update to the medical device at the configuration device, where the record includes identifying information for the given medical device and identifying information for a user associated with the medical device, where the user of the configuration device differs from the user of the medical device; and

communicating the record of the product update from the configuration device to the update interface.

10. The method of claim 9 further comprises receiving the record for the product update by the update interface and updating an audit database regarding the product update.

11. The method of claim 9 further comprises querying the update interface for latest version of a given product update and communicating the latest version of the given product update from the update interface to the configuration device in response to the query.

12. The method of claim 11 further comprises requesting an upgrade for the given product update by the configuration application and downloading the given product update from the update interface to the configuration device in response to the upgrade request.

13. The method of claim 12 further comprises verifying download of the given product update by the configuration application and communicating a confirmation message regarding the download to the update interface from the configuration application to the update interface.

14. The method of claim 10 further comprises creating an entry for the given product update in the audit database, the entry having identifying information for the configuration device, identifying information for a user of the configuration device and identifying information for the medical device.

15. The method of claim 14 wherein the entry for the given product update in the audit database further includes identifying information for a user associated with the medical device.