Regulations, Standards, and Frameworks

ISO 13485:2016 Medical devices — Quality management systems:

It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This standard outlines requirements for a quality management system (QMS) specific to the medical device industry. It ensures organizations design, develop, produce, install, and service medical devices while maintaining a compliant QMS. This includes aspects like risk management, design control, and corrective actions. Adhering to ISO 13485 helps ensure medical devices meet regulatory requirements and are safe for users.

IEC 62304:2006 Medical device software — Software life cycle processes:

This standard focuses on the software development life cycle for medical devices. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. It provides requirements for software design, development, testing, and maintenance. IEC 62304 helps ensure medical device software are designed with security in mind, reducing the risk of vulnerabilities and cyber-attacks. 

ISO 81001-1:2021, IEC/CD TS 81001-2-1, 2-2, IEC 81001-5-1:2021:

Health software and health IT systems safety, effectiveness, and security

ISO 81001 encompasses a suite of standards focused on the safety, effectiveness, and security of health software and health IT systems throughout their lifecycle. ISO 81001-1:2021 lays down foundational principles and concepts, providing a common framework for stakeholders, organizations, governments, and developers to manage these systems. IEC/CD TS 81001-2-1 and IEC/CD TS 81001-2-2 offer guidance on implementation, disclosure and communication of security needs, risks and controls, addressing unique lifecycle processes and emphasizing risk management, quality assurance, and interoperability. Finally, IEC 81001-5-1:2021 concentrates on security activities across the product lifecycle, detailing requirements, and controls to mitigate threats and enhance overall security. Collectively, these standards ensure comprehensive management of safety, effectiveness, and security in the defining, developing, and maintaining security for the medical device software. 

ISO/IEC 27001:2022 Information security, cybersecurity, and privacy protection — Information security management systems:

ISO/IEC 27001 is a globally recognized standard for information security management systems (ISMS). It acts as a standard for organizations to design ISMS for risk management, cyber-resilience and operational excellence. It emphasizes risk management, requiring organizations to identify, assess, and mitigate information security risks through a comprehensive set of controls across various domains, including access control, cryptography, and physical security. The standard promotes continuous improvement by encouraging regular monitoring, reviewing, and updating of the ISMS to adapt to evolving threats. 

ISO/IEC 27002:2022 Information security, cybersecurity and privacy protection — Information security controls:

While ISO/IEC 27001 outlines the requirements for an ISMS, ISO/IEC 27002 offers best practices and control objectives related to key cybersecurity aspects including access control, cryptography, human resource security, and incident response. The standard serves as a practical blueprint for organizations aiming to effectively safeguard their information assets against cyber threats. By following ISO/IEC 27002 guidelines, companies can take a proactive approach to cybersecurity risk management and protect critical information from unauthorized access and loss.

ISO 14971:2019 Medical devices — Application of risk management to medical devices:

This standard provides a framework for applying risk management to medical devices. It helps manufacturers identify, evaluate, and mitigate risks associated with their devices. The standard outlines a systematic process for risk analysis, risk evaluation, risk control, and post-production monitoring, ensuring that medical devices are safe for use and that any potential hazards are mitigated effectively. It involves risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. By following ISO 14971, manufacturers can ensure their devices are designed with safety and security in mind.

MDSAP:

The Medical Device Single Audit Program (MDSAP) is a voluntary program that allows medical device manufacturers to undergo a single audit from a MDSAP recognized Auditing Organization to meet the requirements of multiple regulatory authorities. MDSAP audits, conducted by authorized third-party organizations, ensure compliance with ISO 13485 (QMS) and specific regulatory requirements of each participating country. By adopting MDSAP, manufacturers can achieve global regulatory compliance more efficiently, save time and resources, and enhance patient safety.

CFR 820 Part 11:

This part of the US Code of Federal Regulations (CFR) outlines requirements for electronic records and signatures in the pharmaceutical and medical device industries. It ensures that electronic data is trustworthy, reliable, and equivalent to paper records. Compliance with CFR 820 Part 11 is essential for medical device manufacturers that use electronic systems to manage data. By adhering to this, organizations can ensure that their electronic records and signatures are trustworthy and compliant with FDA standards.

NIST 800-171:

NIST 800-171 is a set of guidelines developed by the National Institute of Standards and Technology (NIST) that provides recommended requirements for protecting controlled unclassified information (CUI) in non-federal systems and organizations. The framework outlines security measures across 14 families, including access control, incident response, and risk management, aiming to safeguard the confidentiality of CUI. Medical device manufacturers, especially those handling sensitive information, may find NIST 800-171 useful for ensuring the security of CUI, such as patient data and proprietary information, which could be crucial in maintaining the overall security posture of their operations. However, ISO 14971 and 62304 are more specifically tailored for medical device security.

HIPAA:

The Health Insurance Portability and Accountability Act (HIPAA) is a US law that protects the privacy and security of individuals’ medical records and personal health information. Medical device manufacturers that manage protected health information (PHI) must comply with HIPAA regulations, including implementing security measures to protect PHI from unauthorized access.

GDPR:

The General Data Protection Regulation (GDPR) is a European Union (EU) law that protects the privacy and personal data of individuals within the EU. It imposes strict requirements on organizations that collect, process, and store personal data. Medical device manufacturers that manage personal data of EU residents must comply with GDPR requirements, including implementing data protection principles, and reporting data breaches. By adhering to GDPR, these organizations can ensure the protection of patient data, avoid substantial fines, and build trust with users by demonstrating a commitment to data privacy and security.

SOC1 & SOC2:

System and Organization Controls (SOC) 1 and 2 are auditing standards developed by the American Institute of Certified Public Accountants (AICPA). SOC 1 focuses on internal controls related to financial reporting, while SOC 2 evaluates controls related to security, availability, processing integrity, confidentiality, and privacy. SOC 2 reports are more directly applicable to medical device security and achieving SOC 2 compliance demonstrates a commitment to protecting data and ensures that robust security practices are in place. 

CMMC:

The Cybersecurity Maturity Model Certification (CMMC) is a US Department of Defense (DoD) program that requires defense contractors to implement cybersecurity controls to protect sensitive information. CMMC consists of five maturity levels, with Level 1 being basic and Level 5 being advanced. For medical device manufacturers involved in defense contracts or those handling FCI (Federal Contract Information) and CUI (Controlled Unclassified Information), achieving CMMC compliance is crucial. It ensures robust cybersecurity practices are in place, protecting sensitive information from cyber threats, and demonstrating a commitment to meeting the DoD requirements. Finally, it positions manufacturers to participate in defense-related projects.

FEDRAMP:

The Federal Risk and Authorization Management Program (FEDRAMP) is a US government program that provides a standardized approach to security assessment, authorization, and continuous monitoring for cloud products and services. Medical device manufacturers providing cloud-based services to federal agencies must comply with FEDRAMP requirements. It demonstrates that their cloud services meet rigorous federal security standards, ensuring the protection of sensitive information and facilitating compliance with government requirements.

FIPS 140 – Security Requirements for Cryptographic Modules:

FIPS 140 (Federal Information Processing Standard Publication 140) is a U.S. government standard that specifies the security requirements for cryptographic modules protecting sensitive information. Hence, Federal agencies must use FIPS 140-validated cryptographic modules for protecting sensitive information, ensuring compliance with federal information security policies. It ensures that the cryptographic mechanisms used in their devices meet stringent security standards, protecting patient data from unauthorized access and breaches. Medical devices often manage sensitive patient data, which must be encrypted to ensure confidentiality and integrity. FIPS 140 provides a benchmark for cryptographic modules used in medical devices, ensuring that data encryption meets federal standards.