How MedTech manufacturers can move cybersecurity upstream, strengthen traceability, and prepare for faster vulnerability response.
AdaptHealth is investigating a material cyberattack after attackers used a social engineering scheme to compromise a third-party contractor’s account, stealing patient data from its cloud-based systems as reports link the breach to the ShinyHunters extortion group, though the attribution remains unconfirmed.
MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Jaimon Jose, senior director of engineering and compliance at CharmHealth, is a software architect and technical leader with more than 18 years of product development experience in the areas of identity and security technologies, distributed systems, cloud security, and data…
By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.
Without formal policies and governance, MedTech organizations face risks to intellectual property, product quality, and ultimately patient safety. Thoughtful AI governance enables development teams to capture efficiency gains while maintaining the rigor that the industry demands.
In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.
No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.
A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from workflows that continue to waste time for both patients and providers.
Patient Preference Information (PPI) guidance on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA.
In this part 1 of a 4-part series, we look at how the burden of digital transformation is impacting the entire healthcare ecosystem, and that while burnout in healthcare is most often framed around clinicians, it does not reflect where the full transformation work is actually being carried…or its impact across healthcare.