This article was produced by Olswang LLP, which joined with CMS on 1 May 2017.
This article was first published in the December 2014 issue of eHealth Law & Policy (volume 1 issue 11).
The UK's Information Commissioner's Office (ICO) launched an informal survey in November into the current practices relating to the use of data-enabled medical devices and apps. "Medical devices are becoming increasingly 'smart'and massmarket," said Stephen Reese and Ross McKean of Olswang LLP. "These devices offer great opportunities, but they also present new and challenging regulatory issues given the sensitivity of the data collected."
The short anonymous survey enquires, amongst other things, as to whether organisations have put in place policies, procedures and security requirements for medical device procurement, information governance and incident response.
"The informal survey is a clear indication that the ICO will be scrutinising medical devices much more closely in future," adds McKean. "Given the nature of the data and the risk of harm if medical data is compromised, ensuring that data-enabled medical devices comply with data protection laws is and will remain a high priority for the ICO and their enforcement team."
