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The Clinical Trial Sponsor's Roadmap To Avoid EMA (Cyber) Perdition

Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on. ....

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Digital Health Apps SaMD Incorporating Privacy In Design Development

Digital Health Apps SaMD Incorporating Privacy In Design Development
meddeviceonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from meddeviceonline.com Daily Mail and Mail on Sunday newspapers.

Ann Cavoukian , Louise Buccolo , John Giantsidis , Cyberacta Inc , International Medical Device Regulators Forum , Expert Network , Health Insurance Portability , General Data Protection Regulation , Privacy Rule , Accountability Act , Ontario Data Protection , Privacy Commissioner , Fresenius Medical Care North America ,

CMS Takes Aim At Medical Device Cybersecurity How To Ensure Continuous MedicareMedicaid Coverage

CMS Takes Aim At Medical Device Cybersecurity How To Ensure Continuous MedicareMedicaid Coverage
meddeviceonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from meddeviceonline.com Daily Mail and Mail on Sunday newspapers.

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Are You Ready For The FDA's "Data Effect" Tsunami 8 Steps To Prepare

Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare
By Matt Collins, CEO, Cignyl; and John Giantsidis, president, CyberActa, Inc.
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan (TMAP). Announced on March 3, 2021, DMAP is the agency’s overhaul of technology and data with the objective of bringing together increasingly disparate and diverse data sources to help understand and pinpoint emerging public health threats.
This sounds very noble, and using data as the basis of the FDA s regulatory decision-making seems to be an improvement. So, why would this be a tsunami for biotechnology, pharmaceutical, and medical device manufacturers? Do not misunderstand, data turned into knowledge improves understanding, decision-making, and, ultimately, outcomes. Businesses have learned this and are continuously improving their use of analytics as a competitive differentiator. However ....

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AIML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval

AI/ML-Enabled Medical Devices â 4 Keys To Obtain Global Regulatory Approval
Artificial intelligence (AI) and machine learning (ML) are disrupting and improving our world. With intelligent machines capable of high-level cognitive processes like thinking, perceiving, learning, problem-solving, and decision-making, coupled with advances in data collection and aggregation, analytics, and computer processing power, AI and ML present opportunities to complement and supplement human intelligence. Application of AI and ML in medical devices is making possible AI/ML-driven diagnostics and personalized treatments.
Artificial intelligence has the potential to provide incremental value to medical device designers and manufacturers and is expected to be the key source of competitive advantage for firms that adopt it. Global regulators have understood that AI and ML models do not fit well within the current medical device regulatory framework and are feverishly working to achieve a ....

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