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.
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.
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.
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.
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 cyber 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:
- Board of directors
- Global health agencies, and other regulators
- Privacy regulators
- Cyber insurers
- Development partners
- Commercial partners
- Employees and contractors
Contact us today.