Should we be worried

About state-sponsored attacks against hospitals?

Security and the Board Need to Speak the Same Language

How security leaders speak to thier C-Suite and Board can make all the difference

The Rising Threat of Offensive AI

Can we trust what we see, hear and are told?

Who'd want to be a CISO?

Challenging job, but increasingly well paid

Medical Tourism - Growing in Popularity

Safe, fun, and much, MUCH more cost-effecitive

The Changing Face of the Security Leader

The role is changing, but what does the future hold?

Cyber Risk Insurance Won't Save Your Reputation

Be careful what you purchase and for what reason

A Pattern of Complacency

A recent story which ran on CBS News entitled “How medical devices like pacemakers and insulin pumps can be hacked” highlighted deficient plans and processes by the US Food and Drug Administration for addressing medical device cybersecurity compromises. The report issued by the Inspector General has been disputed by the FDA which says that it has worked proactively on the issue with security researchers and ethical hackers to identity and fix many of the problems.

This may be the case, but the fact remains that the industry as a whole has been largely in a state of denial over the breadth of depth of cybersecurity vulnerabilities in medical devices and has been very slow to inventory and remediate risks – even when researchers have shown evidence that many security vulnerabilities pose a significant patient safety concern.

The FDAs close working relationship with manufacturers and its preference for constructive ‘guidance’ rather than ‘enforcement’ has been criticized many times before. Despite a growing body of evidence of medical devices being hacked in research lab environments and live on stage at security conferences around the world dating back nearly a decade, it is only within the last couple of years that new devices were forced to undergo any sort of cybersecurity risk assessment prior to being approved for use on patients. Some say the FDA acted too slowly to bring about change and that nobody yet has really dealt with the legacy device problem. Medical devices have long expected life-cycles and more expensive systems like X-ray, CT and PET scanners are often depreciated over 15+ years, meaning that near-term replacement of insecure legacy devices is not a feasible option.

Whatever the case, the fact remains that most manufacturers have not taken any sort of proactive role to risk assess the security of their legacy devices in use today, even when informed of security vulnerabilities long before public disclosure. The onus for risk assessment of these devices currently seems to be placed squarely on the shoulders of providers, who in turn are ill-equipped to assess or remediate problems. Solving this problem will take a strong and concerted effort on all sides with robust leadership and oversight provided by the FDA.

The issues highlighted in the CBS report is remarkably similar to another case that I wrote about in 2016 concerning St Jude Medical, (now owned by Abbott Labs). Despite being informed of major patient safety risks to its implanted Cardiac Rhythm Devices (pacemakers), St Jude Medical chose not to do anything about these risks till Muddy Waters Capital made an example of the company by trading on futures while engaging a security firm to hack and disclose significant weaknesses in the St Jude devices, thus gaining from a downward adjustment of the St Jude stock price.

The St Jude disclosure caused the first ever FDA intervention in medical device security after mass public concern. The fact however remains that security vulnerabilities in medical devices are likely not limited to only a few manufacturers, but common across the thousands of vendors and hundreds of thousands of medical devices that are in circulation globally. Many, of not most of these are responsible for keeping patients alive. The trouble is that we don’t really know the true extent of vulnerabilities and the risks posed to patients by these potentially insecure devices.

Manufacturers do not have programs to risk-assess and penetration test their legacy medical devices and only the most recently approved devices were tested at all from a cyber risk perspective – all other testing being primarily functional in nature, in order to obtain FDA approval.

Hospitals and other healthcare delivery organizations that use or surgically implant medical devices in people’s chests rarely if ever test medical devices either. Even devices that remain in hospitals like network attached morphine and insulin pumps, X-Ray and CT scanners are rarely tested for their cybersecurity vulnerabilities, let alone devices that leave with patients and may not be seen again.

Without testing and without performing a thorough and bone-fide risk assessment to NIST SP800-30 standards in line with HIPAA and OCR requirements, we will probably never really know just how big a problem this is across the entire industry.

Until such times as a full forensic examination of implanted medical device takes place, rather than simply being burned or buried with the patient, we will probably never know the true number of deaths caused by device failure, how these devices failed exactly and whether a cyber-attack against the device caused its failure and the premature death of the patient.

The United States does a great job of evaluating and under-writing all kinds of risks – everything from crop yields, to natural disasters, to the likelihood of flood, fire or theft, yet as a country we really are rolling the dice when it comes to medical risk, and particularly medical device risk. In short, we as a nation, are gambling on the security of the medical devices that keep many of our citizens alive each day.

Third Party Vendor Risk Management

Richard Staynings addresses the need for better Third Party Risk Management @VAHIMSS18
Lets face it, most Healthcare Covered Entities do a lousy job of managing risk - especially cyber risk in a world where data is flowing everywhere to meet government Meaningful Use requirements. In fact as an industry, we almost myopically interpret risk to refer to clinical procedures or hospital-borne post operative infection rates. In an HDO, risk is all about patient safety. But patient safety is much more than clinical risk, it includes the availability of IT systems to diagnose, monitor and treat patients; its about being sure of the validity and integrity of health IT data in order to treat patients; and it includes the entire healthcare delivery supply chain.

Cyber risks in healthcare are not just confined to the data center, to nursing stations or to the PHI data that flows back and forth between health insurers, HIEs, government agencies and patients. The risk web is very much bigger than that. It includes thousands of suppliers, vendors, and partners that stretch right the way across the globe. Everything from business process and IT outsourcers in India, to complex manufacturing supply chains for medical equipment in China, Brazil, Germany, the UK and Australia. It includes the company that provides hot meals to patients and food and coffee for the hospital cafeterias, to the pharmaceutical companies conducting clinical trials, and biomedical engineering companies that provide prosthetic limbs to your patients or an IMD that leaves the hospital with them. Anyone in fact who has physical access to your sites, network access to your IT, or who processes your data, regardless if they ever see one of your patients or not.

A recent Vendor Vulnerability Index research report released by Bomgar, showed that breaches occurring from third parties account for two-thirds of the total number of reported cyber breaches. The study found that only 46% of US companies said they know the number of log-ins that could be attributed to vendors and that less than 51% enforce policies around third party access. Furthermore, 69% of respondents said they 'definitely' or 'possibly' suffered a security breach resulting from vendor access in the past year.

Lets not forget that the Target breach of 40 million credit cards and 70 million customer records was caused by weak security of one of Target's HVAC vendors. It cost Target over $300 million and the jobs of everyone on the leadership team as well as lasting damage to the store's reputation.

The consensus by security professionals is that the risk posed by third parties is not only substantial, but it is increasing each and every year. Gartner stated in its June 2017 Magic Quadrant for IT Vendor Risk Management that by 2020, 75% of Fortune Global 500 companies will treat vendor risk management as a board-level initiative to mitigate brand and reputation risk. So why is it then, that health system CEOs are focused on other things? It could be that the healthcare industry has SO MANY challenges that TPVRM is just further down the list, it could be the fact that very few HDOs feature in the prestigious Fortune 500 list, or it could just be that healthcare CCOs, CROs and CISOs, just haven't gotten the message across to their CEO yet. Either way they need to!

I shared a number of tips and suggestions during my presentation today at the VAHIMSS Annual Conference to aid executives to construct or refine their TPVRM process. My slides can be found here.

Thanks to everyone who attended and asked some great questions and to the leadership of sponsors of the conference who helped to put on a great 3 day event in Williamsburg, VA.