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  Published Paper Details:

  Paper Title

An Overview on Cybersecurity Regulations for Medical Devices in United States

  Authors

  Satya Sakshi,  Himanshu Gupta

  Keywords

Medical Devices, Cybersecurity, Encryption, Malicious

  Abstract


Cybersecurity for medical devices focuses on protecting systems and data from unauthorized access and threats through measures like encryption, authentication, access controls, and updates. The FDA's recommendations stressed the importance of adding security measures to devices. Issues including device complexity, outdated systems, and supply chain vulnerabilities make security more challenging. The FDA is in charge of cybersecurity regulations for medical devices in the US, which prioritize secure design, risk management, and lifetime threat monitoring through premarket and post-market standards. Important frameworks like the 21st Century Cures Act address vulnerabilities, yet there are still problems with standardizing practices and protecting legacy technology. AI-driven security and stricter laws to improve gadget safety are examples of emerging developments. In conclusion, robust cybersecurity laws are necessary to protect medical devices against changing online threats while maintaining patient safety and data integrity.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2512538

  Paper ID - 298927

  Page Number(s) - e786-e800

  Pubished in - Volume 13 | Issue 12 | December 2025

  DOI (Digital Object Identifier) -   

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  Satya Sakshi,  Himanshu Gupta,   "An Overview on Cybersecurity Regulations for Medical Devices in United States", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.13, Issue 12, pp.e786-e800, December 2025, Available at :http://www.ijcrt.org/papers/IJCRT2512538.pdf

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ISSN: 2320-2882
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Journal Starting Year (ESTD) : 2013
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ISSN and 7.97 Impact Factor Details


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ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
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