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Vol.1 — August 14, 2026
MSC Portal Regulatory Watch All Entries (36)
Standards, Guidance & Notices
Showing 21–30 of 36
NIST
SP
SP 1800-30
Securing Telehealth Remote Patient Monitoring Ecosystem
PUBLISHED NEW Cybersecurity
Increasingly, healthcare delivery organizations (HDOs) are relying on telehealth and remote patient monitoring (RPM) capabilities to treat patients at home. RPM is convenient and cost-effective, and its adoption rate has increased. However, without adequate privacy and cybersecurity measures, unauthorized individuals may expose sensitive data or disrupt patient monitoring services. RPM solutions engage multiple actors as participants in patients’ clinical care. These actors include HDOs, telehealth platform providers, and the patients themselves. Each participant uses, manages, and maintains different technology components within an interconnected ecosystem, and each is responsible for safeguarding their piece against unique threats and risks associated with RPM technologies. This practice guide assumes that the HDO engages with a telehealth platform provider that is a separate entity from the HDO and patient. The telehealth platform provider manages a distinct infrastructure, applic
Published: 2022-02-22
NIST
SP
SP 800-218
Secure Software Development Framework (SSDF) Version 1.1: Recommendations for Mitigating the Risk of Software Vulnerabilities
PUBLISHED NEW Software Life Cycle
Few software development life cycle (SDLC) models explicitly address software security in detail, so secure software development practices usually need to be added to each SDLC model to ensure that the software being developed is well-secured. This document recommends the Secure Software Development Framework (SSDF) – a core set of high-level secure software development practices that can be integrated into each SDLC implementation. Following these practices should help software producers reduce the number of vulnerabilities in released software, mitigate the potential impact of the exploitation of undetected or unaddressed vulnerabilities, and address the root causes of vulnerabilities to prevent future recurrences. Because the framework provides a common vocabulary for secure software development, software purchasers and consumers can also use it to foster communications with suppliers in acquisition processes and other management activities.
Published: 2022-02-03
NIST
SP
SP 800-53A Rev. 5
Assessing Security and Privacy Controls in Information Systems and Organizations
PUBLISHED NEW Risk Management
This publication provides a methodology and set of procedures for conducting assessments of security and privacy controls employed within systems and organizations within an effective risk management framework. The assessment procedures, executed at various phases of the system development life cycle, are consistent with the security and privacy controls in NIST Special Publication 800-53, Revision 5. The procedures are customizable and can be easily tailored to provide organizations with the needed flexibility to conduct security and privacy control assessments that support organizational risk management processes and are aligned with the stated risk tolerance of the organization. Information on building effective security and privacy assessment plans is also provided with guidance on analyzing assessment results.
Published: 2022-01-25
NIST
SP
SP 800-213
IoT Device Cybersecurity Guidance for the Federal Government: Establishing IoT Device Cybersecurity Requirements
PUBLISHED NEW Cybersecurity
Organizations will increasingly use Internet of Things (IoT) devices for the mission benefits they can offer, but care must be taken in the acquisition and implementation of IoT devices. This publication contains background and recommendations to help organizations consider how an IoT device they plan to acquire can integrate into a system. IoT devices and their support for security controls are presented in the context of organizational and system risk management. This publication provides guidance on considering system security from the device perspective. This allows for the identification of device cybersecurity requirements—the abilities and actions an organization will expect from an IoT device and its manufacturer and/or third parties, respectively.
Published: 2021-11-29
NIST
SP
SP 800-213A
IoT Device Cybersecurity Guidance for the Federal Government: IoT Device Cybersecurity Requirement Catalog
PUBLISHED NEW Cybersecurity
This publication provides a catalog of internet of things (IoT) device cybersecurity capabilities (i.e., features and functions needed from a device to support security controls) and non-technical supporting capabilities (i.e., actions and support needed from device manufacturers and other supporting entities to support security controls) that can help organizations as they use Special Publication (SP) 800-213 to determine and establish device cybersecurity requirements. This catalog cross references the capabilities in the catalog to the cybersecurity controls in NIST SP 800-53. Organizations should refer to SP 800-213 as that publication provides necessary context to effectively use this catalog and related material.
Published: 2021-11-29
NIST
IR
IR 8259B
IoT Non-Technical Supporting Capability Core Baseline
PUBLISHED Cybersecurity
Non-technical supporting capabilities are actions a manufacturer or third-party organization performs in support of the cybersecurity of an IoT device. This publication defines an Internet of Things (IoT) device manufacturers’ non-technical supporting capability core baseline, which is a set of non-technical supporting capabilities generally needed from manufacturers or other third parties to support common cybersecurity controls that protect an organization’s devices as well as device data, systems, and ecosystems. The purpose of this publication is to provide organizations a starting point to use in identifying the non-technical supporting capabilities needed in relation to IoT devices they will manufacture, integrate, or acquire. This publication is intended to be used in conjunction with NISTIR 8259, Foundational Cybersecurity Activities for IoT Device Manufacturers and NISTIR 8259A, IoT Device Cybersecurity Capability Core Baseline.
Published: 2021-08-25
NIST
SP
SP 1800-24
Securing Picture Archiving and Communication System (PACS): Cybersecurity for the Healthcare Sector
PUBLISHED NEW Cybersecurity
Medical imaging plays an important role in diagnosing and treating patients. The system that manages medical images is known as the picture archiving communication system (PACS) and is nearly ubiquitous in healthcare environments. PACS is defined by the Food and Drug Administration (FDA) as a Class II device that “provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.” PACS centralizes functions surrounding medical imaging workflows and serves as an authoritative repository of medical image information. PACS fits within a highly complex healthcare delivery organization (HDO) environment that involves interfacing with a range of interconnected systems. PACS may connect with clinical information systems and medical devices and engage with HDO-internal and affiliated health professionals. Complexity may introduce or expose opportunities that allow malicious actors to compromise the confidentiality, integrity, an
Published: 2020-12-21
NIST
IR
IR 8259C
Creating a Profile Using the IoT Core Baseline and Non-Technical Baseline
DRAFT Cybersecurity
The core baseline in NISTIR 8259A, IoT Device Cybersecurity Capability Core Baseline and the non-technical baseline in NISTIR 8259B, IoT Manufacturer Non-Technical Supporting Capability Core Baseline can be expanded upon based on more specific contextual information. Using source material with information pertinent to IoT device customers’ needs and goals, the central concepts of the NISTIR 8259 series can be used to guide the development of new elaboration on device cybersecurity capabilities an IoT device may need and the non-technical supporting capabilities that may be needed in relation to the IoT device. This process of expanding on the core baseline and non-technical baseline using additional contextual information is called profiling. A process by which readers of the NISTIR 8259 series can profile source documents is described in this publication.
Published: 2020-12-15
NIST
SP
SP 800-53B
Control Baselines for Information Systems and Organizations
PUBLISHED NEW Cybersecurity
This publication provides security and privacy control baselines for the Federal Government. There are three security control baselines (one for each system impact level—low-impact, moderate-impact, and high-impact), as well as a privacy baseline that is applied to systems irrespective of impact level. In addition to the control baselines, this publication provides tailoring guidance and a set of working assumptions that help guide and inform the control selection process. Finally, this publication provides guidance on the development of overlays to facilitate control baseline customization for specific communities of interest, technologies, and environments of operation.
Published: 2020-12-10
NIST
SP
SP 800-53 Rev. 5
Security and Privacy Controls for Information Systems and Organizations
PUBLISHED NEW Risk Management
This publication provides a catalog of security and privacy controls for information systems and organizations to protect organizational operations and assets, individuals, other organizations, and the Nation from a diverse set of threats and risks, including hostile attacks, human errors, natural disasters, structural failures, foreign intelligence entities, and privacy risks. The controls are flexible and customizable and implemented as part of an organization-wide process to manage risk. The controls address diverse requirements derived from mission and business needs, laws, executive orders, directives, regulations, policies, standards, and guidelines. Finally, the consolidated control catalog addresses security and privacy from a functionality perspective (i.e., the strength of functions and mechanisms provided by the controls) and from an assurance perspective (i.e., the measure of confidence in the security or privacy capability provided by the controls). Addressing functionalit
Published: 2020-12-10
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