Information Sources
There are many organizations, regulations, standards, and frameworks that are part of implementing great security, quality, and regulatory compliance. Below are some good sources of more information. Manor Associates has in-depth knowledge of them and is available to help understand and address them.
Manor Associates white papers
Life Sciences and AI: Top 10 Critical Security Issues
Top 5 Overlooked Security Precautions when Deploying on AWS
Industry Resources
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U.S. Food and Drug Association (FDA)- Medical Devices - https://www.fda.gov/medical-devices
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European Union Medical Device Regulation (EU MDR)- European Medicines Agency - https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
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Privacy Regulations- European Union General Data Protection Regulation (GDPR) - https://commission.europa.eu/law/law-topic/data-protection/data-protection-eu_en- European Data Protection Board - https://edpb.europa.eu/edpb_en- United Kingdom Data Privacy - https://www.gov.uk/data-protection- California Data Privacy (CCPA & CCPR) - https://oag.ca.gov/privacy/ccpa- International Association of Privacy Professionals - https://iapp.org/
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Cybersecurity- ISO - https://www.iso.org/standard/27001- NIST - https://www.nist.gov/cybersecurity- SOC - https://www.aicpa-cima.com/resources/landing/system-and-organization-controls-soc-suite-of-services- HIPAA - https://www.hhs.gov/hipaa/index.html
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Artificial Intelligence (AI)- U.S. Proposed Regulations - https://www.whitehouse.gov/ostp/ai-bill-of-rights/- European Union Proposed Regulations - https://www.europarl.europa.eu/topics/en/article/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence
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Medicare Payment Regulations- MACRA/MIPS/QPP - https://qpp.cms.gov/