This week FDA released several crucial guidance documents that are strongly relevant to cybersecurity. In regulatory fashion, the documents have very different names and are easy to tell apart, making it easy to talk about them at the same time.
That thumping sound is the drumbeat of healthcare cybersecurity news stories. Ransomware, malware, spyware, records theft, covered entities, breaches. Suddenly hospital board members are asking questions about cybersecurity preparedness. That's healthy.
When the board starts knocking, well-meaning CISOs and security teams spring into action, ordering up assessments and other services from a growing cottage industry of third-party security consultants. That's healthy too — healthcare is one of many industries that needs an ecosystem of support around security activities.
The best assessments are sound, complete, and actionable. The worst ones ain't.
Given a statement of work from a third-party assessor, how can you tell whether it's sound, complete, and actionable? That's for a forthcoming post. This post is about one kind of unhelpful assessment: the kind that's only a penetration test.
Clinical engineers (CE) and biomeds need to be in the loop if healthcare organizations can hope to address cybersecurity risks.
Clinicians now have a peer-reviewed guide from a medical journal on how to evaluate when a medical device security problem translates into a clinical risk.
There's been a lot of confusion on risk management for pacemaker and defibrillator security because of the difficulty in explaining medical device security in the context of patient safety and risk management. We are pleased to announce our latest publication on the science and engineering to assess risks of medical device security. Led by Virta Labs, the peer-reviewed paper published in Pacing and Clinical Electrophysiology (PACE) is co-authored by researchers (including four PhDs and two MDs) with backgrounds in electrical engineering, computer science, IT security, and electrophysiology from Virta Laboratories, Beth Israel Deaconess Medical Center, the Mayo Clinic, Zhejiang University, the University of South Carolina, and the University of Michigan Health System.
Topics: Clinical Cybersecurity
(This post is part 2 of 2. Yesterday we wrote about the unfair fight between attackers and defenders. Today: simple tools and techniques.)
If you WannaCry after this weekend's explosion of worm-ridden ransomware afflicting healthcare providers, go ahead; you're not alone.
The good news is that there are concrete steps you can take to assess your organization's level of exposure to WannaCry a
nd the vulnerability it exploits. In this post, we'll share some free, basic tests you can perform using tried-and-true open-source tools. We sell fancy tools to collect and assess networked clinical device inventory, but as technologists and IT administrators ourselves, we're always inclined toward whatever tools get the job done fastest. In this post we'll cover a simple set of tests that you can start running in under a minute.
(This post is part 1 of 2. Tomorrow we'll talk about how we coax identifiers out of clinical devices.)
This week's outbreak of click-less ransomware has not been kind to continuity of hospital operations. The bad guys on the outside know the cybersecurity risks of the clinical networks better than the good guys on the inside. That's not a fair fight. How do the bad guys write such infectious malware? Thanks to easily used tools and public information sources, They know your inventory of software better than you do.
So here's a recommended script for your 7AM emergency cabinet meetings:
1. Offer 60 seconds for your staff to complain about ransomware.
Share a couple horror stories and anecdotes of dodged ransomware bullets. Then stop admiring the problem and focus on your own assets.
2. Biomedical engineering and the IT department need to be on the same page.
In our experience, the best prepared hospitals have a collaborative culture between biomedical engineering and IT. Maybe IT tipped over radiology a few times while trying to "help" biomedical engineering with vulnerability scanning. Don't blame people; you need to work together to continuously assess your population of devices because otherwise the bad guys are going to do it anyway, and not share the results with you.
If your governance structure leads to in-fighting over responsibility and accountability for cybersecurity of networked medical devices, then your governance is broken. If your management does not provide a cybersecurity budget close to the industry standard for health systems, then maybe the Board needs a shake-up (4% of the IT budget is sad, 11% of the IT budget means you worry about nation state threats).
The CEO needs to empower an executive or manager who understands both IT and clinical risk to make cybersecurity decisions. Examples of potential candidates: a nurse with a degree in management of IT systems will likely understand the importance of safety and health outcomes in the context of cybersecurity. An IT manager who volunteers as an EMT will better understand that IT security is a means to an end, and that security must support safe delivery of healthcare.
3. Fix your networked medical device inventory by fixing the process.
Within a hospital, biomedical engineering often owns the database of medical devices for the Joint Commission certification of 99% accuracy of inventory of life-sustaining devices, but IT owns the databases of network inventory. The days of separately managed data ended when your medical devices joined the network. You have to do both at the same time to understand what networked medical device assets are at risk. We find the most mature healthcare systems follow the NIST cybersecurity framework to first enumerate the risks of assets (both tracked assets and shadow IT). Only after getting solid coverage of the asset population can one make risk-based and business-based decisions on how to compensate for security deficiencies in medical devices. Hire an expensive consulting team or buy a product from any healthcare cybersecurity vendor to get a grip on your inventory and prioritized remediations and compensating controls. The third step is most forgotten: continuously measure the effectiveness of your compensating controls because the bad guys certainly do. No security solution will last in perpetuity, so you must constantly verify controls and adapt to shifting threats and new vulnerabilities. But do so in a risk-based manner focused on essential clinical performance. Do not fetishize cybersecurity, for it is merely a means to and end for safe and highly available delivery of healthcare.
We've written before about our sharp and industrious intern Jessica Wilson, who hacks medical devices to learn then better and who has contributed to many parts of BlueFlow, most recently our Active Directory integration.
Medical Device Security is an Inventory Problem
Last week, the American Hospital Association (AHA) interviewed us on how to improve medical device security for its podcast to member hospitals. The AHA represents and serves all types of hospitals, health care networks, and their patients and communities in the United States. Nearly 5,000 hospitals, health care systems, networks, other providers of care and 43,000 individual members come together to form the AHA.
Our colleagues at the AHA get a lot of questions from their members on medical device security. How can a healthcare delivery organization assess the cybersecurity of its inventory of medical devices without resorting to manual entry? How much security is enough? What are the roles of ISAOs?
Topics: Asset Discovery
We have no financial relationship with Muddy Waters Research LLC, St. Jude Medical, or MedSec Ltd. We plan to release a peer-reviewed report shortly so that the greater community may analyze our findings and results.
Topics: Medical Device Security, Clinical Engineering, Healthcare IT, Asset Discovery, Medical Device Risk Scoring, Shadow IT, Vulnerability Scanning, Clinical Databases, Medical Device Risk Assessments