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Life Sciences, Pharmaceutical and Medical Device Companies Need to Trust Less and Question More to Keep High-Value Data Safe
Life sciences, pharmaceutical and medical device companies possess sensitive, high-value data that cybercriminals, hacktivists, unscrupulous competitors and other malicious actors aim to steal or otherwise expose. Personally identifiable information (PII), such as employee data and information about clinical trial participants, is a prime target for compromise. So, too, is intellectual property (IP), like drug formulas, proprietary software and manufacturing processes.
Adversaries are finding success with their campaigns: According to a 2016 study by the Ponemon Institute, which included pharmaceutical and medical device businesses, 90 percent of healthcare organizations (an all-inclusive category for all sectors participating in the survey) have suffered a data breach in the past two years. Ponemon estimates that those incidents cost the healthcare industry US$6.2 billion.
There are other cyber risks, too, that can be even more damaging. The recent, massive WannaCry ransomware attack, for example, shows how the interconnectedness of healthcare systems, and weak security practices, can put both organizations and patients at risk. The malware also affected Windows-based radiology devices at two U.S. hospitals, according to reports. The attackers took advantage of known vulnerabilities in the devices’ software. Many devices across the healthcare system use old software that is difficult to update, which means they are ripe for malicious actors to exploit.
Time to move cybersecurity from “top concern” to “top business priority”
Although cybersecurity is, and has been, a top concern for leadership at life sciences, pharmaceutical and medical device companies and their stakeholders, most of these businesses aren’t doing enough to ensure PII, IP and other vital data, and their critical systems and devices, are protected. There are several reasons for this, including:
- Too much trust: Companies often outsource key critical functions, such as research and development, marketing studies and patient data analysis. Unfortunately, many companies feel that the risk of a data breach or hack is also outsourced to the business partner, and that the collaborative agreements they’ve established with their commercial or academic partners or contracted research organizations somehow guarantee security.
- Lack of insight: Businesses may not dig deeply enough into their collaboration networks or supply chains when conducting cyber assessments to identify security gaps and other risks.
- Too few resources: Many organizations in the industry are small and in startup mode, and therefore operate very lean. They devote most of their time and budget to research and development, which leaves them with little or no funding to put toward enhancing their cybersecurity. Also, many of these businesses rely on cost-effective and easy-to-access technology tools to store and share information, which means information could be exposed to malicious hackers if the tools are not configured and secured properly.
To improve cybersecurity, life sciences, pharmaceutical and medical device companies must stop viewing the issue as a top concern and treat it as a top business priority. As a starting point, these organizations should seek to answer the following questions:
- What information do we share with our strategic partners electronically and how is that data protected while in transit or stored? More companies than ever before, big and small, are now working with contract resource organizations (CROs). These CROs exchange sensitive and confidential data over electronic networks continuously, and the potential for loss, compromise or theft of PII or IP is high. Cybercriminals often will target the security weaknesses of third parties to gain access to a targeted company, using tactics such as phishing. Another risk area: Many businesses are relying on third-party vendors, i.e., cloud providers, to manage and store their data.
- How are our strategic partners handling our information physically at the research site? This question relates to the earlier point about companies’ lack of insight into their collaboration network. Organizations must understand how their information might be exposed in a lab environment or at a research site. The theft, by an insider, of a researcher’s notebook with details about a new drug formula or a medical device in development could spell the end for a company whose entire value is tied up in that irreplaceable IP.
Medical device companies have a third question they should consider (although, so too should the organizations and patients relying on these devices):
- What is the risk that our products could be hacked and/or controlled by malicious actors? The potential for medical device compromise is no longer in the realm of science fiction. And there were warnings that this would become a reality even as the Internet of Things was emerging. Back in 2014, for instance, the U.S. Federal Bureau of Investigation (FBI) issued a report warning that cyber attacks against healthcare systems and medical devices were likely to increase as more healthcare records were digitized and more medical devices were connected to the Internet.
Life sciences, pharmaceutical and medical device companies must think more critically about, and build a better understanding of, their cyber risk exposure and know what digital assets malicious actors would be most likely to target. When it comes to cybersecurity, these businesses would do well to trust less and question more. Failure to do so can put not only their brands and reputations at risk but their entire business — as well as, potentially, the lives of their patients.
Few manufacturers would disagree with the view that the Internet of Things, big data integration and other advances in technology are boosting productivity, streamlining supply and distribution channels, and improving product support. But the WannaCry ransomware attack unleashed on businesses, governments and hospitals across the globe last month and the most recent attack this week delivered a sobering reminder that those digital-driven innovations carry very real risk.
That’s especially true for supply chains. Competition and efficiency demands increasingly compel manufacturers to enlist third-party vendors to produce components for an end product, meaning proprietary information and specification data is sent digitally across the globe, ready for cybercriminals to steal and exploit. One recent survey of 1,400+ supply chain professionals found that data security/IT incidents ranked as the most critical risk to supply chains.
Cyber attacks are likely to grow in frequency and severity, according to our recent Flash Report discussing the WannaCry ransomware event. In the report, we highlighted the need for companies to not only adopt a cyber defense, but also to continuously evaluate and improve it to protect against evolving threats. We noted, again, that many organizations continue to ignore cybersecurity – or at best are inadequately addressing it.
Opaque Supply Chains
It makes sense that businesses that are underprepared in their own cyber defenses have even less insight into the cybersecurity of their suppliers. But clearly they should. According to a 2016 presentation given by cyber supply chain risk management specialist Jon Boyens, a program manager with the National Institute of Science and Technology (NIST), 80 percent of all information breaches occur within the supply chain, and almost 60 percent of companies do not have processes for assessing the cyber security of their vendors. Similarly, more than seven out of 10 organizations lack full visibility into their supply chains.
Even more alarming, NIST anticipated that cyber attacks and data breaches would cause nearly half of the manufacturing supply chain disruptions in the next couple of years. Such incidents are costly. NIST estimated that 55 percent of the disruptions incur more than $25 million in damages per incident. In addition, supply chain breaches that steal or alter data could result in substandard products, the loss of intellectual property, and backdoor access into the manufacturer’s systems, all of which could further tarnish an organization’s brand and diminish its value.
Samsung’s recent bout with the flawed batteries that sparked fires in its Galaxy Note 7 phones illustrates the potential damage to a company’s reputation and bottom line. Samsung ultimately identified specifications provided to its suppliers as the culprit, but not before the company took a $5.3 billion hit to earnings and lost consumer trust. How much worse would it have been if a cyber criminal altered the specifications intentionally?
The good news is that manufacturers can mitigate supply chain risks by ensuring that their third-party vendors are pursuing similar cybersecurity efforts as their own. Here are a few fundamental questions that we recommend focusing on when assessing supply chain IT risk:
- Does the supplier’s culture promote cybersecurity and ransomware awareness throughout the organization? What kind of training are its employees receiving to recognize and address threats?
- What cyber defenses are in place, and are they sufficient to counter the latest malware threats? Is the supplier up to date on indicators of compromise for recent attacks?
- How frequently does the supplier conduct cyber risk assessments? Is the regimen sufficient to keep up with the rapidly evolving threats, and does it include defenses to block operational disruptions? Does the supplier consider the risks in its own supply chain (e.g., Tier 2 and Tier 3 suppliers)?
- Does the supplier have an effective response plan? How often is it updated, and how often does the organization conduct threat simulations as part of its cybersecurity training?
Sound Agreements Needed
Manufacturers and suppliers seeking to reduce supply chain risk also should review contracts to ensure compliance. Items for each party to consider include:
- Are the supplier’s cybersecurity obligations spelled out clearly in the contract, and does the language extend to the supplier’s subcontractors?
- Does the contract include assurances that the supplier has the infrastructure to uphold its end of the contract?
- Who are the executives or managers executing the contract for the supplier? Are they the most appropriate personnel in regards to understanding cybersecurity threats and the supplier’s ability to meet its obligations?
As cyber threats continue to escalate, it is important for manufacturers to gain visibility into their supply chains in order to assess their overall risk-mitigation and response capabilities. The ideas outlined here represent basic but critical actions organizations should be implementing as they strive to secure the increasing amount of sensitive data shared in the production and sourcing processes.