[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45465-45468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18666]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

[Docket No.:190605485-9485-01]


National Cybersecurity Center of Excellence (NCCoE) Securing 
Telehealth Remote Patient Monitoring Ecosystem

AGENCY: National Institute of Standards and Technology, Department of 
Commerce.

ACTION: Notice.

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SUMMARY: The National Institute of Standards and Technology (NIST) 
invites organizations to provide products and technical expertise to 
support and demonstrate security platforms for the Securing Telehealth 
Remote Patient Monitoring Ecosystem for the healthcare sector use case. 
This notice is the initial step for the NCCoE in collaborating with 
technology companies to address cybersecurity challenges identified 
under the healthcare sector program. Participation in the use case is 
open to all interested organizations.

DATES: Collaborative activities will commence as soon as enough 
completed and signed letters of interest have been returned to address 
all the necessary components and capabilities, but no earlier than 
September 30, 2019.

ADDRESSES: Letters of interest must be submitted to [email protected] 
or via hard copy to NIST, NCCoE, 9700 Great Seneca Highway, Rockville, 
Maryland 20850. Organizations whose letters of interest are accepted in 
accordance with the process set forth in the SUPPLEMENTARY INFORMATION 
section of this notice will be asked to sign a consortium Cooperative 
Research and Development Agreement (CRADA) with NIST. An NCCoE 
consortium CRADA template can be found at https://www.nccoe.nist.gov/sites/default/files/library/nccoe-consortium-crada-example.pdf.

FOR FURTHER INFORMATION CONTACT: Jennifer Cawthra via email at 
[email protected]; by telephone, 240-328-4584; or by mail to NIST, 
NCCoE, 9700 Great Seneca Highway, Rockville, Maryland 20850. Additional 
details about the healthcare sector program are available at https://www.nccoe.nist.gov/healthcare.

SUPPLEMENTARY INFORMATION: Interested parties must contact NIST to 
request a letter of interest template to be completed and submitted to 
NIST. Letters of interest will be accepted on a first-come, first-
served basis. When the use case has been completed, NIST will post a 
notice on the NCCoE healthcare sector Securing Telehealth Remote 
Patient Monitoring Ecosystem project page at https://www.nccoe.nist.gov/projects/use-cases/health-it/telehealth announcing 
the completion of the use case and informing the public that NIST will 
no longer accept letters of interest for this use case.
    Background: The NCCoE, part of NIST, is a public-private 
collaboration for accelerating the widespread adoption of integrated 
cybersecurity tools and technologies. The NCCoE brings together experts 
from industry, government, and academia under one roof to develop 
practical, interoperable cybersecurity approaches that address the 
real-world needs of complex information technology (IT) systems. By 
accelerating dissemination and use of these integrated tools and 
technologies for protecting IT assets, the NCCoE will enhance trust in 
U.S. IT communications, data, and storage systems; reduce risk for 
companies and individuals using IT systems; and encourage development 
of innovative, job-creating cybersecurity products and services.
    Process: NIST is soliciting responses from all sources of relevant 
security capabilities (see below) to enter into a CRADA to provide 
products and technical expertise to support and demonstrate security 
platforms for the Securing Telehealth Remote Patient Monitoring 
Ecosystem. The full use case can be viewed at https://www.nccoe.nist.gov/projects/use-cases/health-it/telehealth.
    Interested parties should contact NIST by using the information 
provided in the FOR FURTHER INFORMATION CONTACT section of this notice. 
NIST will then provide each interested party with a template for a 
letter of interest, which the party must complete, certify that it is 
accurate, and submit to NIST. NIST will contact interested parties if 
there are questions regarding the responsiveness of the letters of 
interest to the use case objective or requirements identified below. 
NIST will select participants who have submitted complete letters of 
interest on a first-come, first-served basis within each category of 
product components or capabilities listed below up to the number of 
participants in each category necessary to carry out this use case. 
However, there may be continuing opportunity to participate even after 
initial activity commences. Selected participants will be required to 
enter a consortium CRADA with NIST (for reference, see ADDRESSES 
section above). NIST published a notice in the Federal Register on 
October 19, 2012 (77 FR 64314) inviting U.S. companies to enter into 
National Cybersecurity Excellence Partnerships (NCEPs) in furtherance 
of the NCCoE. For this demonstration project, NCEP partners will not be 
given priority for participation.
    Use Case Objective: The objective of this use case is to provide an 
architecture that can be referenced and guidance for securing a 
telehealth remote patient monitoring (RPM) ecosystem in healthcare 
delivery organizations (HDOs) and patient home environments, including 
an example solution that uses existing,

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commercially, and open-source available cybersecurity products.
    A detailed description of the Securing Telehealth Remote Patient 
Monitoring Ecosystem use case is available at https://www.nccoe.nist.gov/projects/use-cases/health-it/telehealth.
    Requirements: Each responding organization's letter of interest 
should identify which security platform component(s) or capability(ies) 
it is offering. Letters of interest should not include company 
proprietary information, and all components and capabilities must be 
commercially available. Components are listed in Section 3 of the 
Securing Telehealth Remote Patient Monitoring Ecosystem project 
description (for reference, please see the link in the Process section 
above) and include, but are not limited to, those listed in the 
subsections below:

Components for RPM Technologies

 telehealth platform--a solution that enables data and 
communication flow from the patient monitoring device to the home 
monitoring device to the care providers
    [cir] internet-based communications
    [ssquf] transmission of telemetry data
    [ssquf] videoconference
    [ssquf] audioconference
    [ssquf] email
    [ssquf] secure text messaging
    [cir] routing/triage functionality--The telehealth platform enables 
patients to identify an appropriate, networked team of care providers.
    [cir] software development kits (SDKs) and application programming 
interfaces (APIs) that enable telehealth applications to interface with 
patient monitoring devices
    [cir] patient monitoring devices that send telemetry data via the 
home monitoring device
    [ssquf] blood pressure
    [ssquf] heart monitoring
    [ssquf] body mass index (BMI)/weight scales
    [ssquf] other telemetry devices as appropriate
    [cir] home monitoring device (e.g., specialized mobile application, 
stand-alone device) that transmits telemetry data to the telehealth 
platform and provides video connectivity

Components for Remote/Patient Home Environment

 personal firewall--an application that controls network 
traffic to and from a computer, permitting or denying communications 
based on a security policy
 wireless access point router--a device that performs the 
functions of a router and includes the functions of a wireless access 
point
 endpoint protection (anti-malware)--a type of software program 
designed to prevent, detect, and remove malicious software (malware) on 
IT systems and on individual computing devices
 mobile device--a multimodal, small form factor communications 
mechanism that has characteristics of computing devices such as 
wireless network capability, memory, data storage, and processing. The 
device may provide real-time audio, video, and text communications as 
well as support email, web browsing, and other internet-enabled methods 
to interact with locally and remotely stored information and systems.
 modem--a device that provides a demarcation point for 
broadband communications access (e.g., cable, digital line subscriber 
[DSL], wireless, long-term-evolution [LTE], 5G) and presents an 
Ethernet interface to allow internet access via the broadband 
infrastructure
 wireless router--a device that provides wireless connectivity 
to the home network and provides access to the internet via a 
connection to the cable modem
 telehealth application--an application residing on a managed 
or unmanaged mobile device or on a specialized stand-alone device and 
that facilitates transmission of telemetry data and video connectivity 
between the patient and HDO
 patient monitoring device--a peripheral device used by the 
patient to perform diagnostic tasks (e.g., measure blood pressure, 
glucose levels, and BMI/weight) and to send the telemetry data via 
Bluetooth or wireless connectivity to the telehealth application

Components for HDO Environment

 network access control--discovers and accurately identifies 
devices connected to wired networks, wireless networks, and virtual 
private networks (VPNs) and provides network access controls to ensure 
that only authorized individuals with authorized devices can access the 
systems and data that access policy permits
 network firewall--a network security device that monitors and 
controls incoming and outgoing network traffic, based on defined 
security rules
 intrusion detection system (IDS) (host/network)--a device or 
software application that monitors a network or systems for malicious 
activity or policy violations
 intrusion prevention system (IPS)--a device that monitors 
network traffic and can take immediate action, such as shutting down a 
port, based on a set of rules established by the network administrator
 VPN--a secure endpoint access solution that delivers secure 
remote access through virtual private networking
 governance, risk, and compliance (GRC) tool--automated 
management for an organization's overall governance, enterprise risk 
management, and compliance with regulations
 network management tool--provides server, application-
management, and monitoring services, as well as asset life-cycle 
management
 endpoint protection and security--provides server hardening, 
protection, monitoring, and workload micro-segmentation for private 
cloud and physical on-premises data-center environments, along with 
support for containers, and provides full-disk and removable media 
encryption
 anti-ransomware--helps enterprises defend against ransomware 
attacks by exposing, detecting, and quarantining advanced and evasive 
ransomware
 application security scanning/testing--provides a means for 
custom application code testing (static/dynamic)

    Each responding organization's letter of interest should identify 
how its products address one or more of the following desired solution 
characteristics as outlined in Section 3 of the Securing Telehealth 
Remote Patient Monitoring Ecosystem project description (for reference, 
please see the link in the Process section above).
    The primary security functions and processes to be implemented for 
this project are listed below and are based on the NIST Cybersecurity 
Framework.
    IDENTIFY (ID)--These activities are foundational to developing an 
organizational understanding to manage risk.
     Asset management--includes identification and management 
of assets on the network and management of the assets to be deployed to 
equipment. Implementation of this category may vary depending on the 
parties managing the equipment. However, this category remains relevant 
as a fundamental component in establishing appropriate cybersecurity 
practices.
     Governance--Organizational cybersecurity policy is 
established and communicated. Governance practices are appropriate for 
HDOs and their solution partners, including technology

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providers and those vendors that develop, support, and operate 
telehealth platforms.
     Risk assessment--includes the risk management strategy. 
Risk assessment is a fundamental component for HDOs and their solution 
partners.
     Supply chain risk management--The nature of telehealth 
with RPM is that the system integrates components sourced from 
disparate vendors and may involve relationships established with 
multiple supplies, including providers of cloud service.
    PROTECT (PR)--These activities support the ability to develop and 
implement appropriate safeguards based on risk.

 identity management, authentication, and access control--
includes user account management and remote access
    [cir] controlling (and auditing) user accounts
    [cir] controlling (and auditing) access by external users
    [cir] enforcing least privilege for all (internal and external) 
users
    [cir] enforcing separation-of-duties policies
    [ssquf] privileged access management (PAM) with an emphasis on 
separation of duties
    [cir] enforcing least functionality
 data security--includes data confidentiality, integrity, and 
availability
    [cir] securing and monitoring storage of data--includes data 
encryption (for data at rest)
    [ssquf] access control on data
    [ssquf] data-at-rest controls should implement some form of data 
security manager that would allow for policy application to encrypt 
data, inclusive of access control policy
    [cir] securing distribution of data--includes data encryption (for 
data in transit) and a data loss prevention mechanism
    [cir] controls that promote data integrity
    [cir] cryptographic modules validated as meeting NIST Federal 
Information Processing Standards (FIPS) 140-2 are preferred.
 information protection processes and procedures--includes data 
backup and endpoint protection
 maintenance--includes local and remote maintenance
 protective technology--host-based intrusion prevention, 
solutions for malware (malicious code detection), audit logging, 
(automated) audit log review, and physical protection

    DETECT (DE)--These activities enable timely discovery of a 
cybersecurity event.

 security continuous monitoring--monitoring for unauthorized 
personnel, devices, software, and connections
    [cir] vulnerability management--includes vulnerability scanning and 
remediation
    [cir] patch management
    [cir] system configuration security settings
    [cir] user account usage (local and remote) and user behavioral 
analytics
    [cir] security log analysis

    RESPOND (RS)--These activities support development and 
implementation of actions designed to contain the impact of a detected 
cybersecurity event.
     Response planning--Response processes and procedures are 
executed and maintained to ensure a response to a detected 
cybersecurity incident.
     Mitigation--Activities are performed to prevent expansion 
of a cybersecurity event, mitigate its effects, and resolve the 
incident.
    RECOVER (RC)--These activities support development and 
implementation of actions designed to contain the impact of a detected 
cybersecurity event.
     Recovery planning--Recovery processes and procedures are 
executed and maintained to ensure restoration of systems or assets 
affected by cybersecurity incidents.
     Communications--Restoration activities are coordinated 
with internal and external parties (e.g., coordinating centers, 
internet service providers, owners of attacking systems, victims, other 
computer security incident response teams, vendors).
    Responding organizations need to understand and, in their letters 
of interest, commit to provide:
    1. Access for all participants' project teams to component 
interfaces and the organization's experts necessary to make functional 
connections among security platform components.
    2. support for development and demonstration of the Securing 
Telehealth Remote Patient Monitoring Ecosystem for the healthcare 
sector use case in NCCoE facilities, which will be conducted in a 
manner consistent with the following standards and guidance: NIST 
Special Publication (SP) 800-53, NIST FIPS 140-2, NIST SP 800-41, NIST 
SP 800-52, NIST SP 800-57 Part 1, NIST SP 800-77, NIST SP 800-121, NIST 
SP 800-146, Food and Drug Administration (FDA) Radio Frequency Wireless 
Technology in Medical Devices, FDA Content of Premarket Submissions for 
Management of Cybersecurity in Medical Devices, FDA Guidance for 
Industry: Cybersecurity for Networked Medical Devices Containing Off-
the-Shelf (OTS) Software, FDA Postmarket Management of Cybersecurity in 
Medical Devices.
    Additional details about the Securing Telehealth Remote Patient 
Monitoring Ecosystem for the healthcare sector use case are available 
at https://www.nccoe.nist.gov/projects/use-cases/health-it/telehealth.
    NIST cannot guarantee that all of the products proposed by 
respondents will be used in the demonstration. Each prospective 
participant will be expected to work collaboratively with NIST staff 
and other project participants under the terms of the consortium CRADA 
in development of the Securing Telehealth Remote Patient Monitoring 
Ecosystem capability. Prospective participants' contributions to the 
collaborative effort will include assistance in establishing the 
necessary interface functionality, connection and setup capabilities 
and procedures, demonstration harnesses, environmental and safety 
conditions for use, integrated platform user instructions, and 
demonstration plans and scripts necessary to demonstrate the desired 
capabilities. Each participant will train NIST personnel, as necessary, 
to operate his or her product in capability demonstrations to the 
healthcare community. Following successful demonstrations, NIST will 
publish a description of the security platform and its performance 
characteristics sufficient to permit other organizations to develop and 
deploy security platforms that meet the security objectives of the 
Securing Telehealth Remote Patient Monitoring Ecosystem for the 
healthcare sector use case. These descriptions will be public 
information.
    Under the terms of the consortium CRADA, NIST will support 
development of interfaces among participants' products by providing IT 
infrastructure, laboratory facilities, office facilities, collaboration 
facilities, and staff support to component composition, security 
platform documentation, and demonstration activities.
    The dates of the demonstration of the Securing Telehealth Remote 
Patient Monitoring Ecosystem capability will be announced on the NCCoE 
website at least two weeks in advance at https://nccoe.nist.gov/. The 
expected outcome of the demonstration is to improve telehealth RPM 
cybersecurity across an entire healthcare sector enterprise. 
Participating organizations will gain from the knowledge that their 
products are interoperable with other participants' offerings.

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    For additional information on the NCCoE's governance, business 
processes, and operational structure, visit the NCCoE website at 
https://nccoe.nist.gov/.

Kevin A. Kimball,
Chief of Staff.
[FR Doc. 2019-18666 Filed 8-28-19; 8:45 am]
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