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.

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.

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. 

Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions. 

Systems from Change Healthcare are experiencing disruptions for the seventh day in a row after a ransomware attack on parent company UnitedHealth Group.

HHS publishes a new website and releases its essential and enhanced voluntary cybersecurity performance goals.

This week, the FDA extended a comment period on digital health tools to detect diabetes; Theradaptive launched a trial of its spinal fusion device; and devices from Hologic and GE Healthcare won FDA clearance.

As 2024 began, the clamor of voices calling for regulatory reform, including a new EU governance structure for medical devices, had grown to fever pitch. Hot news in January shows how progress is being made. But the likely imminent adoption of the EU’s AI Act could present new issues.

The Office of Strategic Partnerships and Technology Innovation is being expanded to include five divisions, including the Digital Health Center of Excellence.

A new annual report argues that last year was both transformative and historic for the US FDA’s Center for Devices and Radiological Health. The center authorized the highest number of novel medical devices in history while turning the corner on the pandemic.

Views from medtech industry leaders and investors on the most significant uncertainties and opportunities facing the sector in 2024. 

A December report from the GAO urged the FDA and CISA to update a 2018 agreement for medical device security, a recommendation both agencies agreed with.

Attorneys discussing likely False Claims Act trends for 2024 at a recent conference said they have seen more cases involving alleged kickbacks in the form of debt forgiveness and free repairs. They also expected an increase in off-label marketing and cybersecurity cases in the new year.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to King & Spalding’s Eric Henry about the year’s most influential digital health regulations in the US and EU, and what we may have missed in all the excitement.

A new report explains how the Department of Health and Human Services plans to incentivize good cybersecurity practices for healthcare organizations.