New Devices Mean New Risks: The Potential for Liability When Software is a Component of Medical Devices. September 25, 2013

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1 New Devices Mean New Risks: The Potential for Liability When Software is a Component of Medical Devices September 25, 2013

2 The Hartford Insuring Innovation Joe Coray Dan Silverman Providing insurance solutions and keeping its promises to customers for more than 200 years World s Most Ethical Companies by Ethisphere TM Institute for five years in a row 25+ years of experience writing technology & life science businesses of all sizes Since 1995, a strategic partner with Medmarc, serving the life science and medical technology community for more information

3 Indeed, these are Changing Times in Healthcare Technology Medical Devices with embedded software are everywhere, and in all aspects of our healthcare system, including Electronic Healthcare Records (EHR) Embedded in a computer system/software with a dedicated function Unique software designed for the device; and Commercial off the shelf (COTS) Software as components of system within a device Often connected, wirelessly or directly, to Healthcare networks and hospital systems This trend raises software quality and security questions for manufacturers, risk managers and insurance professionals.

4 Trends & Risks in Medical Technology & Life Sciences Patients may be at risk, and will be harmed by, medical device security breach For Medical Device Manufacturers, the risks for devices with embedded software includes: Products liability Civil laws for privacy damage Consequential Loss from software failure Regulatory fines Brand damage Reputation damage Management liability, failure in several duties

5 Susceptibility of medical devices to malware Software in medical devices is becoming increasingly complex; More medical devices are becoming networked with wireless Internet connectivity; Medical devices are evolving from electro-mechanical to software-controlled devices; and Analyzing security after a potential risk becomes a tangible threat would be too late for effective deployment of defensive technology.

6 Case Study Cardiac Science G3 Plus AED FDA has over 28,000 adverse events from AEDs 16% of FDA Advisories were software malfunctions 2011 Study - Software security analysis Windows based utility for updating used Window XP easily exploited Weak Password authentication Credentials stored in plaintext with no encryption Personal Computer used for updating had vulnerabilities

7 Software Quality in Devices Shorter development cycles, less effective software quality testing Testing tools and processes have not kept up with technologies Quality issues are discovered after approval/shipping; manufacturer does not robust plans to resolve Regulatory rules are gray not specific to software quality

8 Other Vulnerabilities MAUDE database doesn t reflect device security Hospitals may not be implementing patches; vendors often are not pushing patches Doctors, not IT professionals, make decisions on which medical devices are used/purchased Wireless medical devices can be controlled by web browsers one of the most vulnerable software types

9

10 Additional Issues with Wireless Medical Devices Most medical devices run older versions of Windows or operating systems, lack current security Concerns that FDA will not permit software patches; medical device companies do not permit operators to apply patches Devices connected on the internet; but do not have secure development and life cycle, may not be current in malware recognition Many Smart Phone Apps in market

11 Barnaby Jack, Homeland ATM remote hacking and beyond Pacemakers too?

12 Implanted Medical Devices hold ephi Data and are Vulnerable Static Data Device make Model # Semi-static Data Physician & Health Center Identification Patient Name and DOB Medical condition Therapy configuration Dynamic Data Patient health status history Therapy and dosage history Audit logs Unsecured Communications Channels In adequate authentication protocols Software vulnerabilities Patient Health Safety Firmware Malfunction Malicious Therapy Update Malicious Inputs to Device Patient Privacy Loss Data Leakage from Device Inappropriate Medical Followup Tampering of Patient Readings

13 In the news in the last couple months May 2013 Dept of Homeland Security issues warning about medical devices that connect to Internet may pose threat to security June 2013 ICS-CERT reported on hard coded password vulnerability in 300 medical devices from 40 vendors FDA is developing a cyber security laboratory working a security company, August 2013 Personal Injury lawyers are watching: "The potential fallout from injuries resulting from tampered devices could mean millions of dollars in claims for damages.

14 Regulatory Actions from FDA Safety Communications Cybersecurity for Medical Devices and Hospital Networks - June 2013 Draft Guidance on Premarket Submissions for Management of Cybersecurity in Medical Devices- June 2013 FDA Guidance on Radio Frequency Wireless Technology in Medical Devices August 2013 FDA Announcement of Consensus Standards changes August 2013 FDA Guidance on Mobile Medical Apps September 2013

15 FDA: Safety Recommendations for Devices Take steps to limit unauthorized device access to trusted users only, particularly for those devices that are life-sustaining or could be directly connected to hospital networks. Appropriate security controls may include: user authentication, for example, user ID and password, smartcard or biometric; strengthening password protection by avoiding hard-coded passwords and limiting public access to passwords used for technical device access; physical locks; card readers; and guards. Protect individual components from exploitation and develop strategies for active security protection appropriate for the device s use environment. Such strategies should include timely deployment of routine, validated security patches and methods to restrict software or firmware updates to authenticated code. Note: The FDA typically does not need to review or approve medical device software changes made solely to strengthen cybersecurity. Use design approaches that maintain a device s critical functionality, even when security has been compromised, known as fail-safe modes. Provide methods for retention and recovery after an incident where security has been compromised. Cybersecurity incidents are increasingly likely and manufacturers should consider incident response plans that address the possibility of degraded operation and efficient restoration and recovery.

16 FDA: Safety Recommendations for Hospitals Restrict unauthorized access to the network and networked medical devices. Making certain appropriate antivirus software and firewalls are up-to-date. Monitoring network activity for unauthorized use. Protect individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services. Contact the specific device manufacturer if there is cybersecurity problem related to a medical device. Develop and evaluate strategies to maintain critical functionality during adverse conditions

17 Guidance for PMA and 510 (k) submissions - June 2013 Develop a set of security controls to assure medical device cybersecurity to maintain information confidentiality, integrity, and availability Consider cybersecurity during design phase Document cybersecurity risk analysis and management as part of the 21 CFR (g) submission Balance between cybersecurity safeguards and usability 1. Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with your device, including: A specific list of all cybersecurity risks that were considered in the design of your device; A specific list and justification for all cybersecurity controls that were established for your device. 2. A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that were considered; 3. To assure continued safe and effective device use, the systematic plan for providing validated updates and patches to operating systems or medical device software, as needed, to provide up-to-date protection and to address the product life-cycle; 4. Appropriate documentation to demonstrate that the device will be provided to purchasers and users free of malware; and 5. Device instructions for use and product specifications related to recommended anti-virus software and/or firewall use appropriate for the environment of use, even when it is anticipated that users may use their own virus protection software.

18 FDA Draft on Wireless Technology August 2013 Considerations for design, testing and use of Radio Frequency and Wireless Recommendations on security of wireless signals and data; risk and risk mitigation, specifically, protection unauthorized wireless access to device, the data stored or hospital network Recommendations on presenting testing data for premarket submissions and labeling of devices

19 Wireless Vulnerabilities

20 FDA Standards of Interoperability and Cybersecurity of Medical Devices August 2013 FDA issued a federal register notice Modifications to the List of Recognized Standards, Recognition List Number: 032 that recognizes voluntary consensus standards to help support and strengthen the interoperability and cybersecurity of networked and connected medical devices. Conforming to these standards can help manufacturers meet certain approval or clearance requirements for medical devices related to interoperability and cybersecurity.: Eight standards related to managing risk in a connected and networked environment; Fourteen foundational standards for interoperability that establish nomenclature, frameworks and medical device specific communications, including system and software lifecycle process; Three cybersecurity standards from industrial control systems area that are most relevant to medical devices.

21 Medical Device Manufacturers - Shielding the IMD

22 HIPAA Omnibus Rule- September 2013 New rule updates privacy, security and enforcement of Health Insurance Portability and Accountability Act Aligns to Health Information Technology for Economic and Clinical Health Act (HITECH Act) and the Genetic Information Nondiscrimination Act (GINA) Under this rule, companies that service medical devices and have access to ephi (electronic Protected Health Information) must comply with HIPAA rules, including breach notification HIPAA requires covered entities to have patch management September 2013 implementation

23 Data Breach: Cyber Risk and Security Cyber Risk is everywhere Private Information made public Networks (and those processes dependent upon them) compromised by intentional or negligent actions. Breaches occur regularly Fines, notifications costs, physical damage, reputation, and liabilities Loss Estimates $110 Billion to consumers, annually from cyber crime $247,000 to $429,000 expense to a business who suffer a data breach $200 per record, in primary cost Untold reputation/brand costs Most Risk Manager are worried Risk management and Insurance can help address this exposure Risk Managers view of danger posed by cyber risk. Source: Zurich. A New Era in Information Security and Cyber Liability Risk Management. A survey on Enterprise-wide Cyber Risk Management Practices, October 2011.

24 General Risk Transfer Tips Wireless network intended to support your medical device must be unambiguously specified to support your application in addition to any other intended applications (e.g. other enterprise traffic on a shared network Intended use of the wireless technology must be consistent with the use of that wireless capability by the medical device Make device security an integral, integrated component of your overall development process. Also, put a higher premium on device security testing most importantly, penetration testing to identify weaknesses in wireless defenses and issue remediation. Secure PHI: What, Where, How, Who, When?

25 Liability Risks for Manufacturers of Medical Devices with embedded software Bodily Injury claims from malfunction Economic Loss from software glitch Reputation, Brand loss from negative publicity Negligence claims for injury from failing to follow guidance, standards, or recommendations Regulatory fines from HIPAA, HITECH or other laws; or other FDA actions Economic Loss from management errors

26 Insurance as tool(s) to mitigate risk Medical Device manufacturers, with devices and embedded software, may need combinations of all these insurance coverages: Products & Clinical Trials Liability Insurance Personal & Advertising Liability Directors & Officers Liability Data Breach Coverage for First Party Cyber Liability Third Party Technology Professional/Errors and Omissions for software developers Product Recall Expense

27 Data Breach & Cyber Risk Coverage First Party and Third Party Coverages Data Breach Expense Coverage Notification Expense Fees and costs for professional crisis management law, public relations or media relations firms Monitoring services for up to one year Good faith advertising services Legal services reimbursement Forensic (information technology) services reimbursement Defense and Indemnity, based on legal liability and damages A per claim deductible generally applies to first party expense coverage. An SIR generally applies to Third Party Liability claims.

28 Professional Liability/Technology E & O Very Common with software and IT insurance Offers defense and indemnity for damages/legal liability arising from failure of the software to perform, breach of warranty Excludes bodily injury, and other GL and Products liability coverages Generally with an SIR

29 Questions, Comments, Feedback Thank you! Joe Coray Dan Silverman The Hartford

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