Attachment 1 - Medical Device Evaluation and Risk Assessment (MDERA) form.docx

DEFENSE HEALTH AGENCY (DHA)

MEDLOG CYBER Logistics Center of Excellence

693 Neiman Street Ft. Detrick, Maryland 21702

Medical Device and Equipment Risk Assessment

MDERA

Version 4.0

To ascertain security compliance that is in agreement with United States Federal Government (USFG), Department of Defense (DoD), and Defense Health Agency (DHA) policies and directives, the DHA Cyber Logistics Center of Excellence (CyberLOG) requires the vendor complete the following Medical Device Equipment Readiness Assessment Questionnaire (MDERA).

All Medical Systems/Devices are required to meet DoD cybersecurity and National Institute of Standards and Technology (NIST) standards. The information provided below will be used as a pre-procurement selection tool used to support all stakeholders working to achieve a Risk Management Framework (RMF) Authorization. Failure to disclose all required information, or misrepresentation of the proposed system’s capabilities, will result in the system being ineligible for purchase, or result in a breach of contract and cancellation of contract if discovered after award.

The information provided below which includes data processing capabilities, current security posture, and level of compliance with the cybersecurity principles of Confidentiality, Integrity, and Availability will be used to identify the technical characteristics of the Medical System/Device and determine the level of effort and potential actions required prior to and during an RMF Assessment process, from a cybersecurity standpoint.

Revision History

Clarified and enhanced questions in Section 2.

Andrew McGraw

READ BEFORE PROCEEDING:

THIS SECTION OF THE CYBERLOG MEDICAL DEVICE AND EQUIPMENT RISK ASSESSMENT (MDERA) QUESTIONNAIRE IS TO BE COMPLETED BY THE COMMERCIAL VENDOR IN ITS ENTIRETY AS PART OF THE MEDICAL DEVICE/SYSTEM REQUEST FOR INFORMATION (RFI) PROCESS. THEREFORE, ALL INFORMATION FIELDS MUST BE ADDRESSED. REFERENCES TO EXTERNAL DOCUMENTS OR PRODUCT LITERATURE ARE NOT ACCEPTABLE.

ONCE COMPLETED, SUBMIT THE MDERA TO THE DESIGNATED POINT OF CONTACT (POC).

COMPLETION OF THIS QUESTIONNAIRE IS APPLICABLE TO REGULATED MEDICAL SYSTEMS/DEVICES AS WELL AS NON-REGULATED MEDICAL SYSTEMS/DEVICES THAT OPERATE IN A HEALTHCARE SETTING.

PRIMARY VENDOR POINT OF CONTACT (POC) INFORMATION (Vendor Account Manager)

Name:

Job Title:

Company:

Business Address:

E-Mail Address:

Phone Number:

Web page Address:

POC Signature and Date:

(Signature indicates acceptance that all provided information is accurate, and that no information has been omitted.)

If Digital Signature is not possible, print and sign this page only. Attach scanned copy to the document.

DATE:

VENDOR TECHNICAL POINT OF CONTACT (POC) INFORMATION (Technical POC Responsible for conducting RMF Activities)

Name:

Job Title:

Company:

Business Address:

E-Mail Address:

Phone Number:

Web page Address:

Technical POC Signature and Date:

(Signature indicates acceptance that all provided information is accurate, and that no information has been omitted.)

If Digital Signature is not possible, print and sign this page only. Attach scanned copy to the document.

DATE:

Section 1: System Identification

MEDICAL DEVICE AND EQUIPMENT IDENTIFICATION – Technical and Regulatory

1.0 Medical Device/Equipment Title/Version:

Provide the naming convention for the medical device/equipment and primary application version.

1.1 Medical Device Description:

Provide a brief technical description of the medical device’s/equipment intended use/capability. If applicable, the FDA 510K Summary Description should be used for accuracy.

1.2 Medical Device/Equipment Model:

List all devices/equipment and versions covered under this review (eg. family of systems)

1.3 Product Suite/Family of Products

Indicate whether the medical device/equipment is marketed by any other model, brand names, trademark, or product suite/family. (eg. Resellers)

1.4 Medical Device/Equipment Category: Recommend use of ECRI Institute’s Universal Medical Device Nomenclature System (UMDNS).

1.6 Food and Drug Administration (FDA 510K)/other Regulatory Certification, or Premarket Authorization identifier, if applicable: Provide the number associated with the medical device/equipment, if applicable.

1.7 Department of Defense (DoD)/Defense Health Agency (DHA) Authorization: State whether the proposed medical device/equipment has been or is currently undergoing the DoD/DHA Risk Management Framework (RMF) Authorization process, and the corresponding eMASS record identifier. State the originating office conducting the RMF efforts, as well as the Authorization Termination Date (ATD).

ATD:

1.8 Baseline physical testing location: Indicate whether an instance of the MDE installed at the manufacturer’s facility is available for RMF Assessment. If such a system is available, provide complete street address.

1.9 Intended Mode of Operation:

Select the intended mode of operation of the medical device/equipment.

|_| Standalone – Operates in complete isolation and thus does not require the use of networking protocols.

|_| Peer to Peer – Operates in complete isolation but requires the use of networking protocols.

|_| Client/Server – Operates as a distributed application that partitions task or workloads between the service requester (client) and the service provider (server) through the use of networking protocols.

|_| Web-based – Operates as a distributed application that requires the use of a browser to access the primary application. There is no client software installed on the client workstation.

|_| Host-based – Operates as a passive subsystem which requires connection a host computer to produce information. It may require the use of networking protocols.

|_| Cloud-based – Operates within a cloud-service environment

|_| Government Cloud Service Provider (eg. DISA, SPAWAR)

|_| Commercial Cloud Service Provider (eg. Amazon Web Service)

1.10 Intended Method of Implementation:

Select the intended method of implementation of the proposed medical device/equipment.

|_| System comprises Hardware + Software + Firmware (traditional configuration)

|_| System is Software Only in a Physical Environment (requires hardware provided by the GOV)

|_| System is Software Only in a Virtual Environment (requires virtual environment)

|_| Virtual Environment must be provided by the Government

|_| Government must provide all Operating System/Database/Application Virtual Servers.

|_| Virtual Environment provided by the Vendor

1.11 Interfaces

Describe how the device connects to the network, or the intended mode for communications.

CONNECTION TYPE:

|_| Serial over RS-232 |_| RJ-45 Networked |_| Serial to RJ-45 Connection |_| 802.11 Wireless |_| Other (Specify Connection Type Below)

1.12 Connected Systems

Describe the types of systems this will connect to, or communicate with. (i.e. PACS, Networked patient monitors, Stand Alone, EHR, etc.)

Section 2: Technical Information

2.0 SYSTEM HARDWARE/FIRMWARE

List all components required for the operation and clinical functionality of the device, to include all servers, workstations, routers, switches, etc.

SYSTEM CONFIGURATION MUST BE DESCRIBED IN ITS ENTIRETY. FAILURE TO DISCLOSE ALL INFORMATION MAY CAUSE A BREACH OF CONTRACT.

2.1 OPERATING SYSTEMS

For each Component Listed in Section 2.0, List the Operating System (OS): Make sure to identify all instances regardless of platform (i.e. server, client, peer, standalone, and portable peripheral end point device), End of Life (EOL) date and intended operational environment (i.e., physical, virtual)

EACH COMPONENT FROM SECTION 2.0 MUST BE LISTED. FAILURE TO DISCLOSE ALL INFORMATION MAY CAUSE A BREACH OF CONTRACT.

No

No

No

2.2 INSTALLED APPLICATIONS

For each Component Listed in Section 2.0, List the Applications required for the System to operate/meet clinical requirements. Make sure to identify all instances regardless of platform (i.e. server, client, peer, standalone, and portable peripheral end point device), End of Life (EOL) date and why the software is required.

EACH COMPONENT FROM SECTION 2.1 MUST BE LISTED. FAILURE TO DISCLOSE ALL INFORMATION MAY CAUSE A BREACH OF CONTRACT.

2.3 Individually Identifiable User Accounts:

For each Component Listed in Section 2.0, describe the account types that are required for the system to operate. Are individual accounts for clinicians required for the application.

EACH COMPONENT FROM SECTION 2.1 MUST BE LISTED. FAILURE TO DISCLOSE ALL INFORMATION MAY CAUSE A BREACH OF CONTRACT.

Describe how accounts are created (site setup accounts, vs vendor default) List all account types in the table below:

SYSTEM ARCHITECTURE DRAWING:

2.4 Medical Device Architecture Diagram: Provide a block diagram depicting all subsystems and components of the proposed medical system/device as configured in your proposal. Include connection specifications such as: Ethernet Connection, Wireless Connection or Bluetooth Connection. You may include an embedded Microsoft Visio diagram with your submission.

2.5: MIGRATION PATH

For any application, or Operating System listed above, with less than 24 months of support/extended support, describe the migration plan, or upgrade path to maintain compliance.

2.6 END POINT PROTECTION - ANTI-VIRUS / HOST BASED SECURITY SYSTEM (HBSS) / HOST-BASED INTRUSION PREVENTION SYSTEM (HIPS)

a. Provide a summary describing if 3rd party/Government Furnished applications can be installed on the proposed medical device/equipment. (i.e. Antivirus, HBSS, monitoring agents (SPLUNK, TANIUM, etc.)

b. If validation is required prior to installation, describe the validation process.

c. If the system does not support these applications, does the system utilize a native White Listing program (or other technology) to effectively mitigate the vulnerabilities associated with not supporting End Point Protection?

a.

b.

c.

Antivirus/Antimalware Heuristics scanning supported?

Does the system provide notification of malware detection in the device user interface or through other mechanism (describe below)?

Does the system automatically update malicious code protection mechanisms? (If no, describe below how malicious code protection mechanisms are updated)

2.7 – VULNERABILITY SCANNING POLICY

Indicate limitations for the ability to run vulnerability scans (i.e. Nessus/ACAS scans) against the device.

MDE can be scanned in a test/vendor lab environment only.

No scanning capability at all (Serial/no networking capability)

MDE can be scanned in a live environment

Provide a summary describing if Network Vulnerability scans can be run against the device while in a live environment, and any limitations to the ability to scan the device in real time. (i.e. restrictions on running scans while conducting a study, system must be “de-hardened” and coordinated with the vendor prior to scanning, etc.).

If the MDE cannot be scanned in a live environment, but can be scanned in a vendor test lab, describe in detail the limitations to scanning within the live environment. (Impact to patient safety, etc.)

2.8 - VULNERABILITY MANAGEMENT/PATCHING POLICY

Provide a summary describing the plan for providing validated software updates and patches throughout the life cycle of the medical device/equipment. Include timeframes to approve patches, if critical OS patches can be installed without vendor permission. The summary should describe how the security patch is validated and then installed (e.g. remote installation by the vendor or distribution by the vendor for biomedical personnel at the healthcare organization to install.) The vendor should also specify the frequency of product updates.

2.9 REMOTE ACCESS

Can the medical device be serviced remotely (i.e., through the use of a secure point to point encrypted network connection)

Can the device be configured to require the local use to accept or initiate remote access?

Does the device provide an explicit indication of use to users physically present at collaborative computing devices?

Does the device require unrestricted access to the Internet in order to provide remote access?

2.10 WIRELESS CAPABILITIES

(IEEE 802.11)

Does the system employ wireless communication?

Wireless Mode of Operation ad hoc? (eg. Device connects internally to another wireless system component)

Wireless Mode of Operation infrastructure? (eg. Device connects to a LAN Environment)

Wireless Authentication Method (eg. PKI, User-name/Password, Token)

Wireless Encryption Method (eg. AES-256 CCMP)

IEEE 802.15 BLUETOOTH

(Wireless Personal Area Network – WPAN)

Use FIPS 140-2 validated cryptographic modules for data in transit, including digital voice communications.

Bluetooth Discovery Mode Turned Off by default.

WIRELESS – Other (Describe any other wireless capabilities, i.e. Ultrawide band, Zigbee, etc.)

2.11 – MASS STORAGE

Provide a summary describing if the use of USB Thumb Drives/External Hard Drives is required for the operation of the system. Are drives required for use by the operator, or administrative in nature? Please detail what information is stored on the drives, how information on the drives is protected, and alternatives to using the drives.

Section 3: Data Processing Capabilities SYSTEM IDENTIFICATION – Data Processing, Electronic Protected Health Information/RMF Authorization

3.0 Data Processing Capabilities:

Does the proposed medical device/equipment perform any of the following data processing functions? (check all that apply) |_| Receive |_| Process |_| Store |_| Transmit |_| Display

3.1 Electronic Protected Health Information/Personally Identifiable Information (ePHI/PII):

(as defined by HIPAA Security Rule, 45 CFR Part 164) Indicate whether the proposed medical device acquires, processes, stores, displays/routes ePHI.

|_| Yes |_| No

3.2 Non ePHI/PII information

Define any data processed that is not ePHI/PII information.

|_| Dates of Birth, Admission, Discharge, Death, and all ages over 89 [and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older] |_| Social Security Number |_| Telephone numbers |_| Fax number |_| E-Mail address |_| Medical Record Number |_| Health Plan beneficiary number |_| Account number |_| Certificate/License number |_| Any vehicle or other device serial number |_| Device identifier or serial numbers |_| Web Uniform Resource Locator (URL) |_| IP address |_| Finger or voice prints |_| Photographic/Radiographic images |_| Test Results |_| Physiologic data with identifying characteristics |_| Biometric data |_| Personal Financial Data |_| Any other unique identifying number, characteristic, or code.

3.4 DoD Information Persistence/Electronic Protected Health Information/Personally Identifiable Information (ePHI/PII) storage method:

Describe the persistence of the DoD Information processed/stored/transmitted on or by the system.

|_| Permanently |_| Temporarily Describe the method in which data is removed from the MDE, and amount of time for data storage. (i.e., First in First Out, removed upon system reset, manually removed, etc.)

3.5 Data Input Method

Describe the data input method. Distinguish between manual versus "prescribed" (automated/programmed) data input methods.

3.6 Data Workflow

Indicate what data elements enter the MDE, and what data elements leave the MDE. Indicate how data is processed and, or changed by the MDE.

3.7 Data At Rest Encryption Capabilities

Describe any capability to encrypt data at rest. Include Encryption method and key strength (i.e. Bitlocker, AES-256)

3.8 Data in Transit Encryption Capabilities

Describe any capability to encrypt DoD Information/ePHI/PII while in transit. Include Encryption method and key strength (i.e. AES-256)

VENDOR: DO NOT COMPLETE ANYTHING BEYOND THIS POINT

IDENTIFICATION INFORMATION

RFO/Contract Number:

ACN:

CE POC:

Contracting POC:

Assigned CyberLOG Container (based on answers in Sections 2.6-2.8) End Point Protection:

|_| Yes (1) |_| No (0) Scanning:

|_| Yes (1) |_| No (0) Patching:

|_| Yes (1) |_| No (0) Assigned Container:

(000 – 111)

Need to cover how information was gathered/verified, etc.

2.678

UNCLASSIFIED//FOR OFFICIAL USE ONLY WHEN COMPLETED

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