A recently published international cybersecurity standard goes beyond what regulators currently require of medtech manufacturers, say attorneys at King and Spalding. If adopted by the US FDA and others, it could add significant burden on medical software developers.
International standards organizations have adopted a new cybersecurity standard for medical devices that goes beyond just looking at a product’s risk level as required by the US Food and Drug Administration, say attorneys at King and Spalding.
In a 8 February blog post, King and Spalding attorneys Eric Henry, Lisa Dwyer and Jessica Ringel wrote that...
A Deep Dive into Evidence-Based Guidelines, Clinical Considerations, and Evolving Practices for Post-SBRT Imaging in Spinal Tumor Patients
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.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
The EU IHI’s eighth call for action also encourages innovative medtech approaches to tackling cardiovascular disease and osteoarthritis and patient-centered endpoints that can benefit from advancements in digital health.
