PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Instead, the Therapeutic Goods Administration (TGA) will classify AI and ML under software as a medical device (SaMD) when it is intended for diagnosis, prevention, monitoring or treatment or alleviation of disease.

NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules. India's Ministry of Health has reached out to the public for consultation on its national digital health blueprint that seeks to propel digital health care, including the use of AI in the biotech and medical technology sectors.

The FDA's regulation of artificial intelligence (AI) is divided by product center for reasons that are obvious, but precisely what that regulation will look like is anything but. As the FDA's Center for Devices and Radiological Health (CDRH) goes through the comment period for its discussion draft for AI, other nations are starting their own efforts in this space. The American agency's efforts may foreshadow the approaches employed in other nations.

Screening for early signs of cognitive impairment and dementia amongst the elderly is a task that's often unevenly attended to by primary care physicians. But the routine personal consumer devices that we use every day might offer a clearer and more consistent window into early declines in cognitive and memory function, according to data from a feasibility study that were reported this week at the Association for Computing Machinery's Knowledge, Discovery and Data Mining conference in Anchorage, Alaska.

Information technology and connectivity have transformed productivity and costs in nearly every industry. Health care, however, has remained persistently immune to this transmogrification. Electronic health records (EHRs) have been particularly disappointing on this front, with time-consuming and inconsistent physician data entry as well as poor integration across complex and emerging data sources from medical devices, imaging, genomics and wearables and, as a consequence, a lack of usefulness in improving population health analytics or personalized care.

The U.S. FDA has cleared the way for Physiq Inc., of Naperville, Ill., to market its continuous ambulatory respiratory rate algorithm, adding to the company's portfolio of cloud-based analytics for biopharma and health insurance companies. The 510(k) notification will allow Physiq to boost its higher-level artificial intelligence (AI) platform with validated vital signs inputs.

LONDON – France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has published draft guidelines on the cybersecurity of medical devices, becoming the first national regulator in Europe to specify what manufacturers should do to protect devices against malicious attacks.

LONDON – Quanta Dialysis Technologies Ltd. has raised £38 million (US$46.7 million) in the first close of a series C round, to fund a U.S. FDA 510(k) submission and U.K. commercial launch of its SC+ home hemodialysis system. With the cash now in hand, both these events are due to occur before the end of 2019. "We've got a lot of work to do," said John Milad, CEO of Quanta. "This is the rocket fuel."

PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.

Two pieces of legislation of interest to the med-tech industry are making the rounds in Washington. One would require that online sales of contact lenses be accompanied only by a prescription, and the other would bolster telehealth services for methamphetamine addiction in rural areas, where the narcotic's epidemic has taken much of its toll. The bills arrive as other developments suggest an improved environment for contact lenses and telemedicine, auguring a better market for both in the months and years ahead.