Researcher queries safety of mobile apps for clinical use

Prominent eHealth researcher Juanita Fernando has called for more oversight of the use of clinical software on personal mobile devices.

Dr Fernando, a researcher in the Mobile Health Research Group with the Faculty of Information Technology at Monash University, said that despite the potential benefits of using clinical software on mobile devices, the lack of legal guidelines covering smartphone and tablet use was concerning.

In an opinion piece in today's Medical Journal of Australia (MJA), Dr Fernando writes that while overseas governments are looking at legal frameworks governing the use of software and apps, Australia is lagging behind.

She called on the federal government to bring together the Therapeutic Goods Administration (TGA) and the Australian Communications and Media Authority (ACMA), both of which regulate certain aspects of clinical software and assistive technologies, with professional organisations to classify clinical software and close regulatory gaps before litigation occurs due to clinical error or security breaches.

She warned of the danger of 'root-kits' – software apps that are installed by manufacturers to monitor program performance but which are also a favourite of malicious users.

“Unknown to the person using a PMD [personal mobile device], root-kits can log keystrokes and user locations and can receive messages without notification,” Dr Fernando wrote. “They often transmit data in unprotected cleartext, too. Another danger concerns the mix of more than 600,000 software applications, both personal and professional, that people, including physicians, install on mobile devices.”

She said almost 70 per cent of American doctors have downloaded and installed clinical software applications, and that Australian physicians are close behind.

“The level of use is alarming because the terms of use of the installed software on PMDs can alter protective device settings, threatening the reliability, and so security, of medical information read on these.

“In the absence of regulatory guidelines, physicians and health organisations need to be cautious about their use of this software, which, when linked to error, may lead to medicolegal consequences.”

One barrier to better governance was the fragmented regulatory system in Australia, with TGA regulations limited to controlling the intended purpose, labelling and advertising claims of clinical software, and ACMA covering assistive technologies on mobile devices for community use, she said.

“Legal uncertainty undermines the confidence with which health organisations and physicians authorise or use PMDs. Physician and organisational confidence in using PMD software for their work, especially diagnosis, would benefit from bringing the TGA and ACMA together with professional organisations to list, evaluate and classify the software.”

She said Australian governments urgently need to support physician confidence in new, emerging and useful technologies to achieve the benefits rather than wait for the results of litigation.

Posted in Australian eHealth

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