A Guide To Protecting Your Life Science Lab

Your #1 Ransomware Vulnerability

At the recent RSA conference in San Francisco Lisa Monaco, the US Deputy Attorney General announced Biotech and Drug Companies have surpassed the financial sector as the most attacked vertical in the last 90 days!

Cybercriminals previously relied on phishing tactics that required social engineering, a slower and more tedious process, to launch attacks. In May 2023, cybercriminals now have a faster, more efficient approach to launch ransomware attacks – medical devices and lab equipment.

Under a new law, FDA submissions must include a “software bill of materials” to prove that newly developed medical devices meet security standards. Regulators have now set a new benchmark with the hope of slowing down the rate of attacks in the coming years.

These new guidelines have raised a crucial concern: “How can life science companies guarantee the security of their existing equipment?”

In light of this, we have put together a guide on protecting your life science lab where we share:

Most significant security concerns for managers of life science labs

What methods are being used to infiltrate these labs

3 ways to increase security with little effort and no financial investment

How to mitigate the dangers of remote access for personal devices

What the future of security for life science labs looks like

ICE's Ulimate Guide to Securing Life Science Labs Cover

Protect your lab and prevent your company from becoming a ransomware headline

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ICE HAS BEEN THE IT AND CYBERSECURITY PROVIDER FOR THE CALIFORNIA LIFE SCIENCE COMMUNITY FOR OVER A DECADE

In ICE'S Ultimate Guide To Lab Security

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International Organization for Standardization (ISO)

ISO compliance is achieved when an organization meets the requirements outlined in a specific standard developed by the International Organization for Standardization (ISO). ISO has developed thousands of standards that cover all areas of business. These ISO frameworks are used by organizations to embed internationally standardized business practices.

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Health Insurance Portability and Accountability Act (HIPAA)

Compliance with the U.S. Health Insurance Portability and Accountability Act (HIPAA) requires companies that deal with protected health information (PHI) to have physical, network, and process security measures in place and follow them. HIPPA laws are a series of federal regulatory standards that outline the lawful use and disclosure of protected health information in the United States.

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Health Information Trust Alliance (HITRUST)

The Health Information Trust Alliance (HITRUST) is a non-profit company that delivers data protection standards and certification programs to help organizations safeguard sensitive information, manage information risk, and reach their compliance goals. HITRUST stands out from other compliance frameworks because it harmonizes dozens of authoritative sources such as HIPAA, SOC 2, NIST, and ISO 27001. It is also the only standards development organization with a framework, assessment platform, and independent assurance program, which has helped drive widespread adoption.

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Clinical Laboratory Improvement Amendments (CLIA)

Clinical Laboratory Improvement Amendments (CLIA) of 1988 contains the Code of US Federal Regulations that govern any entity that returns patient test results for the purposes of caring for that patient. CLIA ensures that there is a standard of quality associated with test results across laboratory testing performed on specimens from humans such as blood, body fluid, and tissue, for the purposes of diagnosis, prevention, or treatment of disease or assessment of human health. This ensures the accuracy, reliability, and timeliness of laboratory test results regardless of where the test was performed.

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National Institute of Standards and Technology (NIST)

NIST was created to improve U.S. innovation and competitiveness across industries “by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life.”
Today, NIST remains one of the nation’s oldest physical science laboratories with a focus on three core competencies:
1. Measurement science
2. Rigorous traceability
3. Development and use of standards
NIST’s technical contributions to the development of information security standards have saved private industries more than $1 billion and drive consumer and business confidence.

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General Data Protection Regulation (GDPR)

The goal of GDPR is to provide more stringent data privacy and security measures and more user-friendly disclosures and reporting on data protection practices. The regulations aim to allow individuals to control the use and storage of their own data, including any personally identifiable information.

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Sarbanes-Oxley Act (SOX)

The Sarbanes-Oxley (SOX) Act of 2002 was passed by the United States Congress into law to cut down on corporations that took part in fraudulent financial reporting. The act was passed on July 30 and its main intention is to protect investors. It’s regularly referred to as the SOX Act of 2002, and it includes strict reforms to previous securities regulations. By mandating these reforms, lawbreakers were now subject to stricter and tougher penalties.

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Service Organization Control 2 (SOC 2)

SOC 2 is coveted and hard to obtain information-security certification, and it demonstrates that an independent accounting and auditing firm has examined an organization’s non-financial reporting control objectives and activities. The auditing firm tests our controls over time to ensure that they are operating securely and effectively. Developed by the American Institute of CPAs (AICPA), SOC stands for Service and Organization Control. It defines criteria for managing customer data based on five “trust services principles” — security, availability, processing integrity, confidentiality, and privacy.

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