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Five Critical Considerations for Connected Health Manufacturers

Leave a Comment / connected health care, cybersecurity, Digital Health, Focus Article, internet-enable devices, MEDdesign, Medical Device, MedTech, user experience design / By

Five Critical Considerations for Connected Health Manufacturers     The hospital of today bears little resemblance to its predecessor of just a few short decades ago, with internet-enabled medical equipment and devices now a central part of diagnosing, treating, and monitoring patients. While these technologies have significantly improved the standard of care, they have also introduced …

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Intelligent Software Connectivity: An Opportunity to Transform Device Development and Health Care

Leave a Comment / connected device, cybersecurity, data-centricity, Digital Health, Focus Article, intelligent software connectivity, interoperability, MEDdesign, Medical Device, MedTech, message-centric software, Product Design & Development / By

Intelligent Software Connectivity: An Opportunity to Transform Device Development and Health Care     The technologies driving minimally invasive and precision healthcare require the integration of robotics, imaging, sensors, and data-driven technologies. MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems. One study estimated that the global market for connected …

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Increasing Momentum in Medical Device Security

Leave a Comment / cybersecurity, Digital Health, EU MDR, IMDRF, legacy devices, MDMs, Medical Device, MedTech, Product Design & Development, Quality/Regulatory, ransomware, SBOM, Soapbox / By

Increasing Momentum in Medical Device Security     In 2021, an employee at Ireland’s public health and social services system—the Irish Health Services Executive (HSE)—opened a spreadsheet that was sent by email. The file contained malware. After two months of free access to the network, the attackers released ransomware into the system. As the BBC reports, …

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Managing Legacy Technology Security

Leave a Comment / cybersecurity, Digital Health, future proofing, HSCC, legacy devices, Medical Device, MedTech, Product Design & Development, risk management, White House / By

Managing Legacy Technology Security     To help address the cybersecurity risks of legacy devices used in healthcare environments, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) has published “Health Industry Cybersecurity – Managing Legacy Technology Security (HIC-MaLTS).” The guide recommends cybersecurity strategies that manufacturers and health providers can implement for …

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New Cybersecurity Standards for Medical Applications

Leave a Comment / connectivity, cybercriminal, cybersecurity, Digital Health, EU, FDA, ISO 810010501, Medical Device, MedTech, risk mitigation, software / By

New Cybersecurity Standards for Medical Applications     An increasing number of pacemakers, insulin pumps and other medical devices incorporate software and can also connect to the Internet, hospital networks or smartphones. In this way, diagnostic data can be transmitted and evaluated in real time using for instance artificial intelligence (AI), thus allowing anomalies to be …

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Prognosis: Medical Device Security Needs Improvement

Leave a Comment / connected devices, cybersecurity, Digital Health, encryption, Focus Article, HIPAA, IoT, Medical Device, MedTech, multi-factor authentication, security breach, Soapbox, TLS / By

Prognosis: Medical Device Security Needs Improvement     The Internet of Things (IoT) has brought many improvements to the healthcare industry. Connected devices make it easier to track hospital resources, transfer critical data and enable telemedicine, but the industry’s increased reliance on these tools raises new concerns. Most notably, device developers, hospitals and regulators have fallen …

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Five Most Common Compliance Problems

Leave a Comment / climate change, compliance, cybersecurity, data storage, Focus Article, human error, Medical Device, MedTech, patient privacy, PHI, Quality/Regulatory / By

Five Most Common Compliance Problems     Regulatory compliance in health care is a vital part of patient care. Regulations create frameworks for best practices among different healthcare organizations. But when it comes to compliance protocols, many healthcare organizations are operating suboptimal or inefficient systems. Two of the major issues in this regard are when healthcare …

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