REAL-WORLD STRATEGIES FOR MEDICAL DEVICE SECURITY

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1 SEPTEMBER 11 13, 2017 BOSTON, MA REAL-WORLD STRATEGIES FOR MEDICAL DEVICE SECURITY HealthcareSecurityForum.com/Boston/2017 #HITsecurity

2 Brian Selfridge Partner, Meditology Services Paul Kerr CISO, Reading Health System 2

3 . Medical Devices: The Weakest Link

4 Medical devices: the weakest link Healthcare data is increasingly valuable Devices are network connected Vulnerabilities make them prime targets Impacts patient safety Data breach and regulatory implications Vulnerable to ransomware attacks Increased reliance on third parties Lots of cooks in the kitchen Regulations and standards lack specificity Real-world Medical Device Hacking Example 4

5 A strong medical device security program: Aligns with industry standards Defines roles and responsibilities Integrates with existing security function Establishes governance Identifies metrics and KPIs Outlines tools and technologies Creates procedures and a multi-year road map 5

6 . Real-World Approaches for Building a Program

7 Communication: establish clear accountability for risk management Mitigation of risk is a business decision. The security program aligns reality with executive risk appetite. 7

8 Communication: governance of the medical device security program Choose VP / C-level constituents with inherent interest and influence as a Steering Committee Make the process simple but engaging Move with purpose: roadmap, risk register, plan, goals and metrics Share the risk burden. Test risk appetite. Cultivate awareness Align with broader IT Governance Demonstrate careful stewardship of money and resources Draw support and visibility. Start and continue the dialogue. Demonstrate progress and accountability. 8

9 Communication: build a foundation of confidence and trust Identify, expose, and interpret risk in business relevant terms Clarify mandate from executive leadership Create an aggressive but achievable plan Advance quickly but execute without impact. Demonstrate progress and preparedness especially during crisis. Earn and maintain credibility with key stakeholders Always educate. Explain the plan at every opportunity Technology is not the hard part. Cultivating and maintaining the organization s care and attention is the key challenge. 9

10 Define roles and responsibilities A RACI chart is used to draw out specific security-related responsibilities to remove ambiguity around who is accountable for an activity s success and who is only helping achieve success. A - Accountable The person held accountable for the decision being made the buck stops here. There is only one A per task. R - Responsible Person(s) who performs the work. C - Consulted Person(s) who are consulted prior to a decision being made or a task completed. Typically a subject matter expert or a functional leader whose team will be affected by the decision/action. I - Informed Person(s) who must be informed after a decision is made or work is completed. Identify the specific person who will be Accountable, Responsible, Consulted, and Informed from each department involved in the program. 10

11 Define roles and responsibilities: RACI examples MDSP Category BioMed InfoSec Technology Communications Develop and deliver progress reports to the Security and Privacy Steering Committee C A, R Develop and maintain medical device security policy C A, R Develop and maintain procedures for securing devices and onboarding devices A, R C Develop and maintain change management procedures including decommissioning A, R C I Asset Inventory & Scanning Create and maintain a detailed device inventory A, R C I Classify devices based on criticality to the patient and extent of ephi contact A, R C Define and maintain device risk rating based on above-mentioned classification C A, R I Maintain medical device vendor relationships, contact information, and contracts A, R I Perform vulnerability scans C A, R Perform vulnerability remediation A, R I Track vulnerabilities and remediation progress C A, R Clarify all key tasks and responsibilities. Document corresponding processes. Partner with operations team be firm but reasonable and flexible. Allow exceptions. Tolerate delays. 11

12 Asset tracking, classification, prioritization Maintain an accurate inventory Leverage automation and scanning tools Explore RFID 12

13 Vulnerability scanning and patching Ensure scanning scope includes medical devices Leverage existing vulnerability scanning tools and processes Limit scanning tools to perform more conservative scan settings Define a patch schedule Scanning and assessment frequency 13

14 Anti malware approach 1) Customer provided anti-virus solution 2) Vendor provided anti-virus solution Define the following processes: Document the date, time and version number of the install in asset inventories Virus pattern update schedule Frequency of scanning (full system scans) Reporting functionality and method for communicating incidents/alerts Incident management expectations and communication Track and document formal scanning exceptions 14

15 Technical security controls Change or disable default accounts and passwords Require multi-factor authentication for remote access Ensure IDS/IPS capability is in place Incorporate devices into audit log aggregation and monitoring solutions Implement restrictions on USB functionality to limit malware infection and data loss exposures 15

16 Medical device vendor risk management Prioritize based on vendor/product risk Leverage surveys like MDS2 Track and monitor progress Monitor alerts from the FBI, DHS, NH-ISAC, and others 16

17 Establish strong partnerships with key stakeholders Legal: new contracts and renewals Ensure standard MSAs include controls and accountability Use your standard MSA, not the vendors Establish the vendor s accountability contractually Procurement: new purchases and renewals Ensure the MDS2 is provided to each prospective vendor as mandatory Evaluate renewal early enough to apply business leverage Project Management Office: new projects Ensure Information Security is considered early in vendor evaluation Insert Information Security review as standard step during planning Reach agreement and document Information Security roles before go-live 17

18 Conduct training example topics: MDSP overview / roles and responsibilities Definition of medical devices Patient safety implications Applicable regulations and standards Examples and case studies of incidents Common security challenges Third party medical device vendor technical and security validation Remote access model Day to day operational impact upon device malfunction or failure Security incident response procedures Review of operational policies and procedures 18

19 Implement network isolation Segment medical devices from the rest of the network Limit to minimum necessary traffic Ensure internet-facing systems are incorporated into a DMZ model Leverage vendor-provided network isolation models 19

20 Define and track metrics Establish clear objectives for tracking progress Create metrics for each key function of the program Establish corrective action plans for underperforming areas Communicate results to governance bodies 20

21 Develop a roadmap 21

22 Brian Selfridge Meditology Services Paul Kerr Reading Health HealthcareSecurityForum.com/Boston/2017 #HITsecurity

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