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Australian Cybersecurity Outlook

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The Changing Face of the Security Leader

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Cyberespionage, and the Need for Norms

Harvard Political Review (external link)

Medical Device Security and CIO Insomnia




During a conversation over drinks with a number of CIOs at a recent healthcare conference, I discovered that the number one concern that keeps most healthcare executives up at night is the security of their medical devices. That was somewhat unexpected, especially following press-grabbing headlines last year about ‘WannaCry’ and other ransomware attacks rendering a large part of the British NHS and other health systems useless for several weeks or months.

Reason 1: Management

Part of their concern is that medical devices are not typically managed by hospital IT (overseen in most cases by the CIO) but by clinical / biomedical engineering staff who power on and attach devices to hospital networks but have little understanding of the cybersecurity risks that are created by connecting an unprotected medical device to the hospital business clinical network. Connected medical devices can by-and-large be compromised easily, used as a foothold on hospital networks, or re-programed to execute patients or hold them to ransom.

This is not fiction! It has been demonstrated numerous times at security conferences most recently by McAfee at BlackHat and Defcon in Las Vegas last month. New Zealand ethical hacker Barnaby Jack started the trend of exposing medical devices vulnerabilities, when in 2011 at the MacAfee Focus Conference he demonstrated a hack of a wireless insulin pump causing the pump to deliver its entire reservoir of insulin into a mock patient. In 2012 he followed this performance up with a hack of a Pacemaker causing the device to administer an 815 volt shock directly to the heart of the mock patient. Both demonstrations would have been fatal to a real patient and that might explain why in 2007 Vice President Dick Cheney had the wireless interface disabled to his own pacemaker at the insistence of Doctors and the US Secret Service. Jack demonstrated the ease at which a patient could be harmed or executed once their Implantable Medical Device or IMD had been hacked. Others followed at subsequent security conferences with hacks of network-attached infusion pumps, reprogramming the device to give a continuous maximum dose of Morphine till the reservoir was empty and the patient likely dead.

Reason 2: Lack of Security

The CIOs second concern is that medical devices have almost no built-in security found on a typical workstation or laptop and cannot readily be patched or upgraded. Nor can security tools and supplicants like anti-malware or a host firewall be installed as the limited capacity of devices will not support the additional memory or processing requirements needed.

To compound these issues, medical device manufacturers are notoriously reluctant and slow to release patches for their devices even when known security vulnerabilities have been discovered. This has resulted in some high profile shaming of manufactures as in the case of Muddy Waters Capital, an Options Trader, against St Jude Medical and the first ever FDA recall of a medical device as a result of the public disclosure. Would the Food and Drug Administration (FDA) have acted if it weren’t for the very public disclosure? It’s hard to tell. Would St Jude Medical have spent any time fixing known security vulnerabilities in some of its pumps? Based upon past performance, it’s highly unlikely. In fact, that was the reason for Muddy Waters penetration test in the first place, thus driving down the share price of St Jude Medical stock, allowing Muddy Waters to profit from its options trades.

The fact of the matter is that most medical devices unless afforded extra layers of protection and defense-in-depth security, are extremely vulnerable to cyberattack. Especially if connected to the main hospital network, let alone allowed to talk to the Internet.

Why are Medical Devices so Vulnerable to Attack and Compromise?

Medical devices take 5 to 6 years to go through testing and clinical trials before they receive FDA approval. The same is true in most other countries. That means that brand new devices arriving in hospitals today were designed at least 5 or 6 years ago using technology that was available at the time. Anyone connecting their 2012 era Windows computer to the Internet tomorrow without any security software or updates would more than likely be compromised inside 10 minutes, yet that’s what we do with medical devices. Only with medical devices, we use them not to surf the web or check email, but to monitor and treat patients - and in some cases keep them alive. That’s where unmitigated risks surface that results in CIO insomnia.

The HIPAA Security Rule (45 CFR (§164.308(a)(1)(ii)(A)&(B) requires a Risk Analysis and ongoing Risk Management be conducted of any and all devices that create, maintain, transmit, or receive ePHI or other sensitive data. Yet most hospitals don’t even have an accurate inventory of their medical device assets so how can they possibly assess their risks? The identification and profiling of medical devices has not been easy for hospitals, most of which have had to rely upon labor-intensive ad-hoc manual discovery processes. New tools and services from CyberMDX and others in the space that can identify and profile medical devices is beginning to change this however. A full asset inventory and medical device profile can now be exported from CyberMDX and entered into an enterprise risk analysis tool such as Clearwater’s IRM|Analysis platform to perform compressive risk analysis to meet the very strict requirements of OCR and HIPAA.

The concern however is a lot deeper than mere HIPAA Compliance and the protection of PHI. Patient safety has become a major worry for healthcare providers where changes to the integrity and programming of medical devices can have far reaching effects. Hackers have already demonstrated the removal of safety limits and have over-written calibration data and dosages and changed drug libraries. Not only is the integrity of medical devices a growing concern but also their resiliency. Most devices will crash or blue screen when a simple virus or multi-cast traffic appears on the subnet. In particular, device availability for patient telemetry systems is critical to alert care staff to patient Codes or other conditions where speedy action on their behalf is required to save a life. Integrity and availability attacks are far more concerning than confidentiality attacks against PHI, and is where the real damage can be done. To date, the OCR has only issued written guidance on the risk analysis of medical devices containing PHI, although audits show that they are beginning to take a broader look at all medical devices regardless of whether they create, receive, store or transmit PHI. The FDA continues to issue guidance, NCCoE and NIST have written a guide to secure medical infusion pumps resulting in NIST Special Publication 1800-8, and the Cloud Security Alliance (CSA) and Open Web Application Security Project (OWASP) recently joined forced to publish a revised Medical Device Deployment Guide. The fact remains however, that numerous medical devices are extremely vulnerable and are not being adequately managed from a risk perspective.

The average cost of a data breach according to Ponemon is $3.8 million. The damage and impact to a hospital’s reputation following a medical device attack resulting in patient death is pretty much unlimited. This may sound a little far-fetched but a recent study by the University of California Cyber Team found that several hospitals had self-reported adverse events from compromised healthcare infrastructure cybersecurity events, like ransomware, malware, or compromised EHRs. The study found that adverse events impacted between 100 and 1,000 patients. Furthermore, the 80 percent of survey respondents that reported risks in medical devices is way higher than what the FDA reports.

Risk Management

Once identified, risks to critical systems should be addressed immediately. When remediation or retirement of a medical device is not possible, effective compensating security controls should be implemented to isolate and protect the device from attack and compromise. Many of the larger hospital systems are turning to micro-segmentation of their medical device network assets using Cisco TrustSec or other tools to essentially white-list network communications to and from each medical device and drop all other traffic. GE Health and Unisys do this by routing all medical device traffic through proxy servers. Others have segmented their medical device VLANs by use of internal firewalls. These solutions all increase the complexity of networks and leave many smaller hospital systems with tight budgets and limited capabilities out in the cold.

What’s being done to harden medical devices and prevent them from being hacked?

Guidance (and its only guidance to date) has been published by the FDA, NIST, NCCoE, CSA/OWASP and others to improve the deployment and security of medical devices. The onus however is squarely being placed upon healthcare providers to secure the medical devices they procure and utilize. At the same time manufacturers are being pressured to improve the security design of their devices and now have to perform a risk analysis of medical devices before FDA approval. But with a 5 to 6-year development cycle, the results of ‘improved security by design’ may take many years to reach hospitals and patients. With a 15 to 20-year lifespan for many medical devices, the security problem is not about to go away any time soon. That means hospitals need to implement compensating security controls immediately and keep them there for the foreseeable future.

Somewhat alarmingly however, a recent Ponemon Report on Medical Device Security showed that despite known vulnerabilities “roughly one third of device makers and healthcare delivery organizations (HDOs) are aware of potential adverse effects to patients due to an insecure medical device, but despite the risk only 17 percent of device makers and 15 percent of HDOs are taking significant steps to prevent such attacks.”


Learn more about Clearwater Compliance and the Company’s innovative information risk management solutions for healthcare organizations.


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Medical device security keeping you up at night?

Clearwater offers healthcare delivery organizations the most comprehensive solution available for improving the security of biomedical devices connected to their networks.Much more than just a traditional vulnerability assessment, Clearwater strengthens its end-to-end, enterprise approach to reducing risks, by automatically identifying, assessing, and managing risk of all wired as well as wireless medical devices.


Discover how our Comprehensive Medical Device Cybersecurity and Risk Management Program can support the unique needs of your organization.

This blog is also published here. To view comments or join the discussion on this article or the questions it raises, please follow the link.

Panaceas, Shiny Objects and the Importance of Managing Risk in a Healthcare Environment – Part 2

Healthcare CIOs, CISOs, and other information risk management leaders face daunting challenges when it comes to deciding where to apply their limited resources to make the biggest difference in their organization’s cyber risk posture. As I mentioned in my previous post, healthcare security leaders can be tempted by shiny new objects – i.e., new security tools – that promise to be the panacea to their most pressing security problems.

Cyber security leaders can also be distracted by Executive Board members and other stakeholders who prioritize the cyber threat of the day. They may respond to cyber attack headlines by button-holing the CISO and asking, “What are we doing about THIS???”

The solution to a scattershot, reactive approach to cyber security is to develop an enterprise cyber risk management system (ECRMS). And the first step in developing an ECRMS, is conducting a HIPAA-compliant risk assessment and analysis.

HIPAA Compliance and Risk Assessment

HIPAA’s Security, Privacy and Breach Notification Rules are designed to ensure the confidentiality, integrity and availability (CIA) of protected health information (PHI). HIPAA’s Security and Privacy Rules apply to any entity that “creates, receives, maintains or transmits protected health information” per 45 C.F.R. § 160.103. This means that whether you are a healthcare provider, a health plan, a healthcare clearinghouse or a business associate of any of this entities, HIPAA applies to you.

The HIPAA Security Rule actually defines three different types of assessments that organizations must conduct in order to be compliant. Those three types of assessments include:
  • HIPAA Security Non-Technical Evaluation, a.k.a. Compliance Gap Assessment
  • HIPAA Security Technical Evaluation, a.k.a. Technical Testing
  • HIPAA Security Risk Assessment/Analysis
The difference between these three types of assessments is a topic for another blog post. What’s important to understand for our purposes is that organizations must conduct all three types of security assessments in order to be HIPAA compliant. One type of assessment (for example, Technical Testing or Compliance Gap Assessment) cannot be substituted for another type of assessment (Risk Assessment/Risk Analysis).

The first step – the foundational step – in developing an enterprise cyber risk management system, is to conduct a security risk assessment and analysis as defined within the HIPAA Security Rule. Two other information sources help to provide a comprehensive and detailed definition of what a HIPAA-compliant risk assessment looks like: first, OCR guidance – including the results of OCR enforcement actions and audits – gives a clear picture of what a comprehensive risk analysis includes. Second, NIST standards around information security provide a model for how to properly conduct a risk assessment – and how to start developing a strategic framework once you have the assessment results.

What an OCR-Quality Risk Analysis Entails

At its most basic level, risk analysis includes three primary tasks:
  1. Identifying risk
  2. Rating risk
  3. Prioritizing risk
Identifying risk starts with identifying and documenting every information asset in your organization. Information assets include all electronic equipment, data systems, programs and applications that are controlled, administered, owned or shared by an organization and which contain, transmit or store ePHI. This includes traditional forms of assets, such as IT systems and applications (e.g., EHR systems, clinical information applications, lab applications, medical billing and claims processing applications, email applications, etc.).

Information assets also include biomedical assets, such as patient monitoring devices, implantable devices, and remote chronic disease management applications. Internet of Things (IoT) assets must also be included in your asset inventory. (Incidentally, a key challenge for hospitals and health systems in conducting a comprehensive information asset inventory has been their capability to identify and document electronic medical devices. New technology from companies such as CyberMDX, CloudPost, Zingbox and others identifies medical devices, device types, software versions and VLAN location via passive observation of biomedical network traffic without threatening a device.)

Risk analysis does not stop with a simple inventory of information assets, however. Risk has three components: an asset, a threat, and a vulnerability. Adequately identifying risk means addressing each of these components for each information asset. For example, an information asset might be a tablet computer used by staff or clinicians. One threat to that tablet could be theft. Vulnerabilities that create risk when that table is stolen include a lack of encryption, weak passwords, and a lack of data backup. In other words, each information asset can be compromised by many different types of threats. In turn, those threats become real due to the vulnerabilities associated with them.



A comprehensive, HIPAA-compliant risk assessment requires documentation of a considerable amount of detail. It’s easy to see how healthcare organizations who attempt to conduct an inventory of information assets, with their associated threats and vulnerabilities, are quickly overwhelmed with pages and pages of spreadsheets.

Rating and Prioritizing Risk

And yet there is more.

Because a bona fide, OCR-compliant risk analysis includes not only identifying information assets, threats and vulnerabilities, but also rating risk. This involves estimating the likelihood (probability) and impact (degree of harm or loss) on the organization of each possible asset/threat/vulnerability combination.

Which makes our spreadsheet even more complex:



After all information assets have been inventoried, all asset/threat/vulnerability combinations have been documented, and the likelihood and impact of each potential risk calculated, the result is a “risk rating” for each potential threat.

The beauty of the risk rating is that it allows each healthcare organization to identify, rate and prioritize the particular risks associated with that organization’s unique information asset inventory, threat/vulnerability combinations, and calculated risks.

Each organization is able to establish their own risk threshold. For example, an organization might specify a risk rating of “20” as their threshold. That means that information risk management strategic priorities would center on mitigating risks for those items that rated 20 or higher. In the example above, security leadership would be able to use this information to make a persuasive case for security tools that enabled encryption of ePHI contained on tablet computers, as the “25” risk rating indicates this risk is a high priority for this organization.

The Value of a Comprehensive Risk Analysis

Conducting an OCR-quality, security risk assessment and analysis has value for healthcare organizations beyond assuring compliance with HIPAA guidelines. As the example above illustrates, a comprehensive risk analysis helps security leaders not only identify, but also rate and prioritize enterprise-wide cyber security threats.

The information uncovered by the risk analysis can help security leaders develop relevant and meaningful cyber risk management systems by providing a framework for making decisions. With an accurate and updated security risk assessment in place, security leaders no longer have to make purchasing decisions based on the strength of a vendor’s demo, or in reaction to cyber threat headlines. With a security risk assessment and analysis in place, healthcare security leaders are empowered to make proactive and strategic decisions about the tools and strategies that will mitigate their highest priority risks.

It’s probably also become clear that conducting an OCR-quality, security risk assessment is not a simple undertaking. Fortunately, it is not necessary to “reinvent the wheel” in order to conduct a comprehensive security risk assessment.

In addition to the language of the HIPAA Privacy, Security and Breach Notification Rules, OCR Guidance, and NIST resources, Clearwater Compliance has developed resources, solutions and services that help healthcare organizations quickly conduct an OCR-quality security assessment.

In the third part of this 3-part series, Panaceas, Shiny Objects and the Importance of Managing Risk in a Healthcare Environment, I will explore some of the resources, solutions and services that can not only help security leaders efficiently conduct a security risk analysis, but also help healthcare security leaders leverage the completed security risk analysis to develop an enterprise cyber risk management system.

Learn more about Clearwater Compliance and the Company’s innovative information risk management solutions for healthcare organizations.

Check out the first blog in this series here: Panaceas, Shiny Objects and the Importance of Managing Risk in a Healthcare Environment–Part 1


This blog is also published here. To view comments or join the discussion on this article or the questions it raises, please follow the link above.

Patient Safety and Cyber Risk







Healthcare CEOs know all about patient safety – at least that’s what they’ll tell you. Joint Commission and others have been all over the subject for years. Ask them what patient safety really means and most will probably start talking about how healthcare organizations protect their patients from errors, injuries, accidents, and infections. It’s a big issue. As many as 440,000 people die every year from preventable errors in hospitals alone. However, only a few healthcare CEOs will include cybersecurity in their list of top risks, but that is slowly beginning to change.

Today’s US healthcare payers, providers and pharmaceuticals are under attack – from state sponsored theft of healthcare IP, clinical formulations, procedures and treatment regimens, to the PII of patients including 78.8 million customers of Anthem Health, to the commercial theft and sale of PHI and PII by cyber-criminal gangs intent on the monetization of stolen data.

What many don’t realize is that cyber risk in a healthcare setting is not just about attacks against the confidentiality of information but also the availability and integrity of health IT systems and data. Healthcare is a prime target for extortion and has been disproportionately impacted by bouts of ransomware impacting the availability of health IT systems to render care to patients.

Just look at the UK NHS when it succumbed to the global WannaCry ransomware attack last year. Nearly two thirds of NHS Hospital Trusts were impacted and had to cancel appointments and divert all but the most critical of emergency patients elsewhere. Had the NHS understood the true magnitude of its cybersecurity risks and acted accordingly to patch and replace out of date systems, then the negative impact to the lives of many of its patients could have been avoided.

I’m sorry, the Doctor can’t see you at the moment – our IT systems are down!


So what happens to patient care when critical Health IT systems aren’t available to diagnose or treat patients? Their surgeries get cancelled, or they get put in an ambulance to an unaffected hospital 40 or 50 miles away. That’s where the patient safety question comes into play.

What is the impact to a sick patient when he or she has to be transported an hour or so to a functional hospital?

What if that patient happens to be many hours’ drive or flight away from the nearest unimpacted and available facility and expires en-route?

What is the level of culpability for healthcare providers when they fail to properly evaluate and protect against availability risks to their IT systems?

There is a fairly obvious duty of care for patient safety so shouldn’t that extend to the availability of health IT systems needed to treat patients?
Should hospitals be held accountable in the same way that we hold retailers accountable when they fail to protect their credit card payment systems?

Modern healthcare is highly dependent upon the clinical IT systems we use to diagnose and treat patients. What happens when a medication cabinet won’t open to dispense critical medications? What happens when a pharmaceutical robot dispenses the wrong medications for a patient and the mistake is not noticed by overworked staff? Our reliance today upon IT and IoT systems is perhaps more than most physicians would willingly admit.

Primum non nocere. (First do no harm)

Making cyber-risk a critical part of enterprise risk across the healthcare industry should be a must, given the potential risks to patient safety, just as evaluating and assessing all assets on the clinical-business should be too. The rising number of non-IT devices plugged in, or connected wirelessly, to hospital networks far overshadows the number of PCs, laptops and workstations in most facilities. What is more, most of these IoT devices have no security protections and cannot easily be patched. Medical devices are growing at 20% per annum and are often owned and managed outside of hospital IT and Security teams. No wonder then, that hospital CEOs are becoming concerned at the patient safety ramifications of one of these devices being compromised by a malicious hacker.

Widespread automation and cost cutting across hospitals is leading to a rising trend of the outsourcing of hospital building management systems (BMS). This includes everything from electrical and water distribution to elevators and HVAC. Most of these outsource agreements are with companies from many miles away – often out of State, or out of Country, who manage systems remotely via a virtual private network (VPN). Usually governed by weak or incomplete third-party contracts which are rarely audited, these agreements extend the hospital attack surface into the outsource company complete with all of their security vulnerabilities. Scholars of prior cybersecurity attacks will be quick to point out the parallels here between Target Stores and its HVAC services provider Fazio Mechanical, which resulted in one of the largest cyber-thefts of credit card numbers as well as most of Target’s customer information. The breach cost Target millions in compensation, restitution and credit monitoring, as well as the jobs of everyone in leadership.

The repercussions of third-party vendor breach in healthcare could however, be far more nefarious and impactful given what is connected to the typical hospital network. That is, unless networks are properly and securely segmented to isolate BMS, medical devices and business IT systems. However very few hospitals have so far even started to securely segment their large flat networks.

The need therefore to evaluate third party risk is critical, yet most hospitals currently don’t do this well if at all. With thousands of suppliers, vendors, contractors and consultants in each hospital, manual assessment is simply too much to handle with the current number of security and compliance staff.

As healthcare leaders continue to monitor and evaluate what is meant by patient safety in their operations, it’s clear that today, patient safety means so much more than just avoiding medical errors or someone slipping on a freshly mopped hospital floor.

The author addresses these and other subjects at the South Dakota HIMSS annual Conference today 
in Sioux Falls, SD.


Panaceas, Shiny Objects and the Importance of Managing Risk in a Healthcare Environment – Part 1



You’re the CISO of a healthcare organization and you just sat through an amazing sales presentation by one of your security vendors. You are considering cutting a PO to purchase that new security tool. You’ve been thinking for some time about purchasing tools to close security gaps that you’re aware of and this particular tool appears to address a critical area of weakness in your information security program.

At the same time, you’ve got limited resources for addressing your healthcare organization’s cybersecurity risk. You experience ongoing challenges around finding and retaining IT staff with expertise in information risk management. You know you’ll need staff resources to implement that new security tool, but your IT budget never stretches quite far enough to cover all of your organization’s technology needs, let alone managing cybersecurity risk.

Sound familiar?

Shiny Object Syndrome' in the security realm is often associated with a myopic focus on one critical area of weakness or vulnerability


Healthcare security leaders are often tempted to buy the “shiny new object” that promises to be the panacea to their most pressing security problems. Perhaps an audit or assessment highlighted the gap and executive management jumped all over it. Perhaps a breach or security incident became a compelling event, and the vendor’s new tool looks like a silver bullet. Vendors often encourage this line of thinking, being only too happy to make another sale.

Though new security tools can be tempting, their purchase is sometimes the result of a myopic focus on a single critical area of weakness or vulnerability. Yet the vast majority of healthcare organizations have many security gaps, spread over a wide range of areas. This is true regardless of the size of an organization’s dedicated IT staff or their information risk management budget.

When a shiny new security tool attracts your attention, how do you determine whether or not this is the best use of your resources? How do you make the case to your Board that purchasing this particular tool should be your organization’s number one priority?

The Changing Cyber Risk Landscape

All too often, healthcare security leaders are put in the position of simply reacting to the latest, headline-grabbing cyber security threats. A short time ago, cyber attackers seemed mostly intent on hacking into healthcare networks in order to steal patient data and sell it on the black market. The consequences of a data breach are far-reaching, including a loss of customer trust, penalties and settlement fees imposed by the Office for Civil Rights (OCR) for HIPAA violations, and the cost of remediation measures. A recent Ponemon Institute report estimates the average total cost of a data breach at $3.86 million. As a result, stakeholders including Board of Trustees members and consumers clamor for assurance that their healthcare providers have tools and strategies in place to prevent data breaches.

But even as data breaches continue to pose a real threat to healthcare organizations, new threats have emerged. Ransomware attacks on healthcare organizations have turned out to be just as lucrative for cyber criminals, if not more so, than selling healthcare records on the black market. The impacts of last year’s WannaCry ransomware attacks have continued to play out in healthcare organizations in the U.S. and in the U.K.

WannaCry compromised IT system availability in order to shake down healthcare providers for ransom money. But other types of emerging malware attacks – such as NotPetya – pretend to be ransomware while actually destroying critical systems and data. The increase in cyberattacks that target system availability have made IT system availability and resiliency the new cybersecurity mantra.

At the same time, new attack surfaces in healthcare organizations are attracting the attention of hackers. Network-attached medical devices – think Internet of Things (IoT) – are just as susceptible to malware and ransomware attacks as other, more traditional targets, such as the enterprise data center.

All this means that cyber risk management in a healthcare organization is a continually moving target. Cyber attackers’ motives, strategies and targets evolve quickly. By the time a new security tool comes on the market, a different threat has emerged, requiring a different approach to risk mitigation.

Given the constantly changing cyber security threat landscape, how is a CISO to respond? Is there a better way to protect your organization than being swayed by the latest, greatest vendor presentation? Is there a better way to protect your organization than yielding to Board pressure to respond to the cyber threat du jour currently making headlines?

The Big Picture: Enterprise Cyber Risk Assessment

The good news is that there actually is a better way.

And the better news is that this “better way” not only helps your organization meet HIPAA compliance requirements, it also helps your organization develop a strategic approach to enterprise-wide information risk management. It’s a deliberate and considered approach that can help guide your organization’s information risk management purchasing decisions and will strengthen your organization’s cybersecurity posture.

It begins with an enterprise-wide cyber risk assessment.

By an enterprise-wide cyber risk assessment, I’m not referring to marking off boxes on a controls checklist. I am also not referring to your latest technical testing, security gap assessment, or pen test. I’m talking about conducting a bona fide, enterprise-wide, HIPAA-compliant, security risk assessment and analysis.

What does a HIPAA-compliant security risk assessment look like?

Stay tuned. I will explore that topic in Part 2 of this three-part blog series: Panaceas, Shiny Objects and the Importance of Managing Risk in a Healthcare Environment.

Learn more about Clearwater Compliance and the Company’s innovative cyber risk management solutions for healthcare organizations.


This blog is also published here. To view comments or join the discussion on this article or the questions it raises, please follow the link.