Healthcare Cybersecurity

Overview

Navigating the Landscape of Healthcare Cybersecurity

Navigation Guide:

Cybersecurity Regulations
General Cybersecurity Standards
Cybersecurity Standards & Regulations for Medical Devices
Key Cybersecurity Themes for Healthcare Devices
Healthcare Cybersecurity Resources

The healthcare sector is increasingly reliant on connected devices and digital systems, which introduces new cybersecurity vulnerabilities. Protecting sensitive patient data, securing medical devices, and maintaining the integrity of healthcare networks are critical to safeguarding public health and trust. As the complexity of healthcare technology expands, navigating the evolving cybersecurity threats in this space has become critical.

Key Cybersecurity Challenges in Medical Devices
Healthcare systems face a unique set of cybersecurity challenges. These range from protecting sensitive patient information to safeguarding medical devices that are vulnerable to attack. Some of the most pressing challenges include:

Exposure of patient data through connected medical devices.
Vulnerabilities in hospital networks and healthcare IT infrastructure.
Compliance with complex and evolving regulations in the healthcare industry.
Increasing sophistication of cyber-attacks targeting critical healthcare systems.

Applicable Cybersecurity Standards & Regulations

Confirming industrial systems are compliant with general and industry-specific cybersecurity standards and regulations is essential for mitigating risks. These standards establish technical requirements on securing networks, devices, and data in complex industrial environments, helping facilitate regulatory compliance and robust cybersecurity practices.

Cybersecurity Regulations

Regulation	Description
Delegated Regulation (EU) 2022/30	This regulation outlines cybersecurity requirements for certain categories of radio equipment, extending the scope of the original Radio Equipment Directive (RED) 2014/53/EU. It focuses on safeguarding networks and preventing unauthorized access, particularly for devices with internet connectivity, confirming they meet applicable security standards before entering the EU market.
EU Cyber Resilience Act (CRA)	The Cyber Resilience Act (CRA) aims to improve the cybersecurity of connected devices and digital products within the EU by imposing mandatory security requirements throughout their lifecycle. Manufacturers, developers, and businesses are responsible for maintaining compliance to enhance product security and protect consumers from cyber threats.
EU NIS2 Directive	The NIS2 Directive strengthens cybersecurity requirements for essential and digital service providers within the EU, expanding the scope of the original NIS Directive. It mandates enhanced risk management and incident reporting obligations for critical infrastructure sectors, including healthcare, energy, and transportation, to protect against cyberattacks.
EU Cybersecurity Act	The EU Cybersecurity Act establishes a framework for cybersecurity certification of products, services, and processes across the EU. It strengthens the mandate of ENISA (the EU Agency for Cybersecurity) and introduces a European-wide certification scheme to promote high standards of cybersecurity for connected devices and systems.
EU Digital Operational Resilience Act (DORA)	DORA focuses on the financial sector, setting cybersecurity standards to validate that financial institutions can withstand and recover from operational disruptions. The regulation requires firms to adopt robust risk management strategies and testing protocols to protect against cyber threats and enhance operational resilience.
EU General Data Protection Regulation (GDPR)	The GDPR is the EU’s data protection law, which sets strict rules on how organizations collect, store, and use personal data. It grants EU citizens certain rights over their data, such as the right to access, rectify, or delete it, and imposes hefty fines for non-compliance to help enforce robust privacy protections across the EU.
UK Product Security and Telecommunications Infrastructure (PSTI) Act	The PSTI Act establishes cybersecurity requirements for consumer connected devices in the UK. It mandates basic security standards, such as banning default passwords, providing security update information, and confirming vulnerability reporting mechanisms, to enhance the security of connected products sold in the UK.
California Privacy Rights Act (CPRA)	The CPRA, an expansion of the California Consumer Privacy Act, strengthens data privacy protections for California residents by creating the California Privacy Protection Agency and introducing new rights, such as the right to limit the use of sensitive personal data. It also increases business obligations around data collection, storage, and usage transparency.
SB-1121 California Consumer Privacy Act (CCPA)	SB-1121, an amendment to the original CCPA, clarifies certain provisions of the law and adjusts its enforcement timeline. The CCPA gives California residents broad rights over their personal data, such as the right to know, delete, and opt out of the sale of their information, applying to businesses that meet specific thresholds for data processing.
SB-327 California IoT Cybersecurity Law	California’s SB-327 is a pioneering law that mandates cybersecurity protections for all IoT devices sold in the state. It requires manufacturers to equip devices with reasonable security features, such as unique passwords and secure authentication protocols, to protect against unauthorized access and data breaches.

General Cybersecurity Standards

Standard	Description
UL 2900-1	A cybersecurity standard that focuses on securing network-connected products and systems. It provides guidelines for identifying vulnerabilities, conducting penetration testing, and performing source code analysis to manage cybersecurity risks. The standard helps manufacturers implement security measures for their products and meet necessary regulatory expectations. UL 2900-1 is commonly applied to validate the security of connected devices in various industries.
IEC 62443 Series	A set of international standards designed to protect Industrial Automation and Control Systems (IACS) from cybersecurity threats. It offers a structured approach for addressing risks in industrial environments, covering areas such as system design, security levels, and access control. By following this series, organizations can enhance the resilience of their industrial systems against cyber threats, supporting the protection of critical infrastructure and operations. The standards are versatile and can be leveraged across various industries, including energy, manufacturing, transportation, and healthcare, to improve the security of industrial systems in different sectors.

Standard

Description

UL 2900-1

A cybersecurity standard that focuses on securing network-connected products and systems. It provides guidelines for identifying vulnerabilities, conducting penetration testing, and performing source code analysis to manage cybersecurity risks. The standard helps manufacturers implement security measures for their products and meet necessary regulatory expectations. UL 2900-1 is commonly applied to validate the security of connected devices in various industries.

IEC 62443 Series

A set of international standards designed to protect Industrial Automation and Control Systems (IACS) from cybersecurity threats. It offers a structured approach for addressing risks in industrial environments, covering areas such as system design, security levels, and access control. By following this series, organizations can enhance the resilience of their industrial systems against cyber threats, supporting the protection of critical infrastructure and operations. The standards are versatile and can be leveraged across various industries, including energy, manufacturing, transportation, and healthcare, to improve the security of industrial systems in different sectors.

Cybersecurity Standards & Regulations for Medical Devices

Standard	Description
IEC 81001-5-1	IEC 81001-5-1 is an international standard that addresses cybersecurity for healthcare products, particularly focusing on medical devices and health software. It specifies requirements for securing the confidentiality, integrity, and availability of medical data, as well as measures for safeguarding patient information from unauthorized access or tampering. This standard provides guidelines for both manufacturers and users to implement security controls throughout the device lifecycle, helping to mitigate cybersecurity risks while maintaining the safety and performance of medical devices.
UL 2900-2-1	This standard is part of the UL 2900 series, emphasizing patient safety, ISO 14971 compliance, structured penetration testing for healthcare systems, secure lifecycle management, and enhanced documentation. It adds layers of protection tailored to the sensitive and regulated nature of healthcare environments, confirming that security breaches do not compromise essential medical functions.
IEC 62443 Series	This series addresses cybersecurity for industrial automation and control systems, including medical devices used in healthcare settings. It establishes security requirements for the entire lifecycle of medical devices, from design and development to deployment and maintenance. By adopting IEC 62443, medical device manufacturers can better secure connected systems against cyberattacks, safeguarding patient safety and the reliability of healthcare infrastructure.
Medical Device Regulation (MDR) 745/2017	The Medical Device Regulation (MDR) 745/2017 sets requirements for the safety, performance, and risk management of medical devices within the EU. It emphasizes the importance of incorporating cybersecurity measures throughout the lifecycle of medical devices to protect against cyber threats that could compromise patient safety and device functionality. Compliance with MDR confirms that manufacturers meet the necessary safety standards to market their devices in the EU.
In Vitro Diagnostic Regulation (IVDR) 746/2017	The In Vitro Diagnostic Regulation (IVDR) 746/2017 governs the safety and performance of in vitro diagnostic (IVD) devices in the EU. Like MDR, IVDR highlights the need for managing cybersecurity risks to safeguard diagnostic data and system integrity. By complying with IVDR, manufacturers of IVD devices can demonstrate that their products meet the regulatory requirements for safety and cybersecurity, enabling them to access the EU market while protecting patients and healthcare systems.

Other Applicable Requirements for Medical Devices

FD&C Act	Standard
FD&C Act Section 524B – Ensuring Cybersecurity of Medical Devices	FD&C Act Section is a statutory provision within the Federal Food, Drug, and Cosmetic Act (FD&C Act). It was added as part of the Consolidated Appropriations Act of 2023 to address cybersecurity for medical devices. Section 524B of the FD&C Act mandates that medical device manufacturers incorporate cybersecurity measures throughout the device lifecycle to address evolving threats. This regulation confirms that manufacturers assess, mitigate, and manage risks related to unauthorized access and potential disruptions to device functionality. By requiring submission of cybersecurity documentation, it helps safeguard patient safety and data integrity.

FD&C Act

Standard

FD&C Act Section 524B – Ensuring Cybersecurity of Medical Devices

FD&C Act Section is a statutory provision within the Federal Food, Drug, and Cosmetic Act (FD&C Act). It was added as part of the Consolidated Appropriations Act of 2023 to address cybersecurity for medical devices. Section 524B of the FD&C Act mandates that medical device manufacturers incorporate cybersecurity measures throughout the device lifecycle to address evolving threats. This regulation confirms that manufacturers assess, mitigate, and manage risks related to unauthorized access and potential disruptions to device functionality. By requiring submission of cybersecurity documentation, it helps safeguard patient safety and data integrity.

Key Cybersecurity Themes for Healthcare Devices

CIA Triad

Cybersecurity Risk

Secure Design

Cryptography

Network Security

Wireless Security

Web Application Security

Mobile Application Security

Embedded Security Systems

Industrial Security

Secure Coding

Cybersecurity Testing

Governance, Risk, and Compliance (GRC)

Secure Software Development Lifecycle (SDLC)