In brief: Pharmaceutical, biotechnology, and medical device companies hold some of the most sensitive and valuable data on earth, which makes them prime targets for cybercriminals. The most effective defense is a right-sized cybersecurity program that matches your organization's size, risk profile, and capabilities, and matures over time. This article outlines where to begin, how to scale, and why third-party risk management belongs at the center of your strategy.
The landscape
Pharmaceutical, biotechnology, and medical device companies generate and manage a lot of sensitive and valuable data, which makes them ideal targets of bad actors. Cybercriminals are constantly finding new ways to steal or ransom data and execute fraudulent transactions for financial gain. Attacks can be highly sophisticated or surprisingly simple, targeted or broad, and automated or personal. They can be aimed at company-owned systems and infrastructure or at trusted partners.
The loss of clinical trial data, intellectual property, and proprietary business information or the release of private health information can be devastating to business continuity and reputations and result in significant losses. Remediation is arduous and expensive. When it comes to preventing cybersecurity incidents, establishing and implementing cybersecurity controls is essential for every life sciences organization.
Cybersecurity is just as important as compliance, product development, operations, or sales. Treating it as a core priority is the first step toward protecting your data, your patients, and your reputation.
Where to begin
USDM Life Sciences thinks about an organization’s cybersecurity in terms of maturity. Improving cybersecurity maturity is a process of continuous improvement. Due to the evolving threat landscape, there is no end-state maturity. Rather, our goal is to achieve levels of cybersecurity maturity that align with risks, threats, company size, company profile, resources, and capabilities and increase maturity over time. Newer, smaller, and leaner companies tend to have lower levels of cybersecurity maturity, while larger, more established, and higher profile companies tend to have resources and capabilities that enable higher levels of cybersecurity maturity.
The first step for any size organization is to recognize that cybersecurity is just as important as compliance, product development, operations, or sales. To address this core priority, organizations should establish a cybersecurity program and ensure that it’s properly resourced. Our life sciences cybersecurity services are designed to help you stand up that program and mature it deliberately.
A common mistake: Companies near the beginning of their cybersecurity journey often try to implement a framework that is far beyond their abilities, then get overwhelmed by the scale and complexity of it all. Start with a framework that fits today and is built to scale.
How to scale your efforts
A good cybersecurity program will fit your organization in terms of size, sophistication, risk, and capabilities, and help you set immediate priorities. Companies near the beginning of this journey often try to implement a framework that is far beyond their abilities and they get overwhelmed by the scale and complexity of it all.
A better approach is to select and implement a framework that fits today and drives cybersecurity maturity over time. The frameworks that USDM prefers are built on the same principals as the National Institute of Standards and Technology (NIST), which help you to address fundamentals first, then increase in sophistication as your company grows. We also recommend prioritizing your security controls and framing them in terms of people, processes, and technologies. This will help you to direct your efforts while working with internal and external partners.
Three lenses for prioritizing your security controls
- People — Roles, accountability, training, and the security culture that determines whether controls are actually followed day to day.
- Processes — Documented procedures for access management, incident response, change control, and the periodic reviews that keep controls effective.
- Technologies — The tooling and infrastructure that enforce your controls, from identity and access to monitoring and data protection.
Strong controls also depend on the integrity of the data they protect. Maintaining data integrity across regulated systems is closely tied to cybersecurity, because a breach that alters or corrupts records is as damaging as one that exfiltrates them.
Think beyond your organization
More than ever, life sciences companies rely on large networks of partners. Your valuable data is with your software, platform, and infrastructure partners, as well as your contract research, development, and manufacturing partners. If they suffer a serious data breach, it has the potential to be just as severe for your organization. Third-party risk management is a critical element of your cybersecurity program and should be formally planned and executed, including dry runs of your incident response plan.
For cloud and SaaS systems that underpin your operations, an ongoing assurance approach such as USDM Cloud Assurance helps keep those validated, regulated environments secure and compliant as vendors push updates and the threat landscape shifts.
Read our latest white paper to discover a comprehensive overview of cybersecurity for medical device manufacturers, including 9 steps to meet FD&C 524B requirements.
How USDM can help
From early-stage life sciences organizations to well-established companies, defending against cybersecurity threats and managing cybersecurity risks is critical. USDM engages knowledgeable and experienced staff that know your industry and your business.
Trust USDM to implement a comprehensive cybersecurity program for your organization to assess your risks, threats and posture; improve your cybersecurity maturity; and help you implement and test controls.
We’ll help you meet the expectations of:
- Patients
- Board of directors
- Global health agencies, and other regulators
- Privacy regulators
- Cybersecurity insurers
- Development partners
- Commercial partners
- Employees and contractors
FAQ: Cybersecurity in life sciences
Why are life sciences companies such attractive targets for cybercriminals?
Pharmaceutical, biotechnology, and medical device companies generate and manage large volumes of sensitive and valuable data — clinical trial data, intellectual property, proprietary business information, and private health information. That concentration of high-value data makes them ideal targets for bad actors seeking to steal, ransom, or commit fraud for financial gain.
What is cybersecurity maturity and why does it matter?
Cybersecurity maturity is a way of describing how advanced and capable an organization's security program is. Because the threat landscape keeps evolving, there is no fixed end-state. The goal is to reach maturity levels that align with your risks, threats, company size, profile, resources, and capabilities — and to increase that maturity continuously over time.
Where should a smaller or newer company start?
Start by recognizing that cybersecurity is as important as compliance, product development, operations, or sales, then establish and properly resource a program. Rather than reaching for a framework beyond your current abilities, select one that fits your organization today and is designed to scale as you grow.
Why does USDM favor NIST-based frameworks?
The frameworks USDM prefers are built on the same principles as the National Institute of Standards and Technology (NIST). They help you address fundamentals first and increase in sophistication as your company grows, while prioritizing controls across people, processes, and technologies.
How does third-party risk affect our cybersecurity?
Your valuable data sits with software, platform, and infrastructure partners as well as contract research, development, and manufacturing partners. If one of them suffers a serious breach, the impact can be just as severe for your organization. That is why third-party risk management — including dry runs of your incident response plan — is a critical element of your program.
Ready to strengthen your cybersecurity posture? Whether you are standing up a program for the first time or maturing an existing one, USDM can help you assess your risks, threats, and posture; improve your cybersecurity maturity; and implement and test the right controls. Contact us today to get started.