「安全分析」Safety_Implications_of_Medical_Device_Cybersecurity-安资源-CSDN文库

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#RSAC

SESSION ID:

#RSAC

SESSION ID:

Suzanne B. Schwartz, MD, MBA

Safety Implications of Medical Device

Cybersecurity

PS-W01

Director, Office of Strategic Partnerships & Technology

Innovation

Food and Drug Administration

suzanne.schwartz@fda.hhs.gov

Margie Zuk

Senior Principal Cybersecurity Engineer

The MITRE Corporation

mmz@mitre.org

© 2020 The MITRE Corporation. All rights reserved. Approved for Public Release: 20-0468. Distribution Unlimited.

#RSAC

2

The products we regulate…

#RSAC

3

Bottom Line Up Front (BLUF)

“Whole of community” approach: Collaboration is key

Security spans across the total product lifecycle

Impact on critical infrastructure within and across sectors

Shifting the mindset:

– Consider scenarios beyond “intended use”

– Integrate threat modeling

– Beware of using probabilistic determinations—these can yield a false sense of

security (avoid ‘likelihood’)

Foster culture and create incentives that encourage proactive behavior,

especially for information-sharing

Major strides made AND acceleration necessary

#RSAC

Framing the Issue

Connected medical devices, like all other computer systems,

incorporate software that are vulnerable to threats

We are aware of cybersecurity vulnerabilities and incidents

that have directly impacted medical devices or hospital

network operations

When medical device vulnerabilities are not addressed and

remediated, they can be exploited which can result in:

– patient harm

– serve as access points for entry into healthcare delivery

organization (HDO) networks

May lead to compromise of confidentiality, integrity, and

availability

4

#RSAC

5

Shared Responsibility

Manufacturers

DHS

Security

Researchers

FDA

Health Care

Facilities

Clinicians

Patients

Professional

Societies

ISAOs

External Stakeholders

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