Cybersecurity

The commission's recently reelected president also wants the new commission to evaluate the need for potential changes to the medtech regulations.

Now European businesses are returning to “normal” after the summer break, they will find key developments have occurred in the EU during the traditional holiday season.

This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.

In this Chinese-language podcast episode, "Angus" Shipo Xie, a lawyer at Han Kun Law, joins Brian Yang to discuss the implications of China's updated Data Overseas Transfer rules issued in late March. Dexter Yan explains clinical data released by Hutchmed, Jiangsu Hengrui and Innovent Bio at the recent EHA and ADA annual conferences.

Device manufacturers still have a low level of cybersecurity maturity, but larger companies seem to be doing better than smaller ones.

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

At the recent Precision Med Tri-Con conference, health care leaders and AI enthusiasts Eric Topol and Doug Flora discussed how AI integration will change the way doctors practice medicine and patients receive care.

A newly enacted regulation in China governing the overseas transfer of data allows waivers under certain conditions but also introduces some new hurdles compared to the draft version.

Medical device cybersecurity is a part of a larger ecosystem that should not—and cannot—be ignored.

Risk-based AI regulations and data modernization are just a few of the top policy priorities from thought leaders attending the largest health care technology professional gathering in the world.