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Redefining Patient Safety

Dena MendelsohnJen Goldsack

Advocates expanding traditional patient safety definitions to incorporate cybersecurity risks, digital footprints, and data rights.

Summary

The Digital Transformation of Clinical Care

Digital health tools, remote patient monitoring devices, and connected home sensors promise enhanced care accessibility but introduce unprecedented risk profiles.

Limitations of Traditional Risk-Benefit Analyses

Conventional clinical risk assessments evaluate biological efficacy and physical toxicity, often ignoring cybersecurity vulnerabilities and third-party data tracking.

Quantifying Harm from Digital Health Footprints

Insecure digital health platforms expose patients to targeted discrimination, loss of insurance coverage, and direct clinical disruption through compromised device communications.

Integrating Cybersecurity into Patient Safety Standards

Health systems and regulatory bodies must modernize clinical governance by embedding data rights and cybersecurity baselines directly into the core definition of patient safety.

Related talks

Biohacking Village·27 min

  • DEF CON
  • Policy
  • Date: Aug 2020
  • Location: Online

Mo Ali · Amy Abernethy

FDA Principal Deputy Commissioner Amy Abernethy discusses medical device cybersecurity, big data, and regulatory collaboration.

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