Cybersecurity & Compliance for Silicon Valley Biotechnology Firms

Exploring the reasons why IT security and compliance are just as important as innovative tech development

Biotechnology and life sciences firms in Silicon Valley deal with a large amount of critical research, patient and business data – and most of it has now evolved into digital and virtual formats. Accordingly, regulatory compliance standards have evolved to better govern the security and access to such sensitive data.

Additionally, Silicon Valley biotech professionals are exposed to greater cybersecurity risks than ever before. Data security breaches are more common than ever and breaches can have serious negative impacts for biotechnology firms including stolen data, ransom payments, hefty fines, legal action, or negative exposure and hits to a firm’s reputation.

We recently worked with a public biotechnology firm of 500 employees from the Silicon Valley to help them beef up their cybersecurity effort. We gave them a full work-up including a business continuity assessment, a PCI compliance audit, a HIPAA compliance audit and a GDPR compliance audit.

They’re now fully protected and compliant. However, our work with this firm got us thinking. We should put together a ‘playbook’ for Silicon Valley biotechnology professionals who are looking to up their cybersecurity game. So, for biotechnology professionals anywhere from Cupertino, to Mountain Valley, to Sunnyvale – and everywhere in between – read on to review the top questions you should be considering when it comes to IT security & compliance.

  1. Does my biotechnology firm really need to worry about cyber attacks?

The short answer to this question is, yes, your Silicon Valley biotechnology firm absolutely needs to be worried about cyber attacks. The fact of the matter is biotechnology and life sciences industries collect and work with a huge amount of very sensitive data sets and have become a prime target for cybercriminals. Biotechnology giants like Nuance and Merck are just some of the most recently hit entities.

These cyber attacks can impact your firm in a variety of ways. Cybercriminals are more sophisticated than ever before and can deploy attacks to infiltrate your networks, steal data, and/or shut down your systems completely.

This can result in massively negative impacts for your firm including:

  • Extended and expensive periods of system downtime
  • Unauthorized data access and theft
  • Compromised compliance resulting in penalties and fines
  • Negative impacts on operational productivity
  • Decreased confidence from both consumers and stakeholders
  • Damage to firm reputation

Therefore, in order to avoid these potentially devastating consequences, Silicon Valley biotechnology professionals need to be aware of existing and potential threats to IT security and compliance. By keeping potential cyber threats top of mind, your firm will approach cybersecurity with a more vigilant and informed approach.

  1. What kind of regulatory compliance should be on our radar?

Now, once you’ve made a deliberate consideration regarding the potential threats you face, it’s also critical that you understand your compliance responsibilities clearly. This goes beyond simple anti-virus or firewall solutions. Because biotechnology professionals collect a variety of personal and sensitive data, there are a variety of regulatory compliance standards to uphold.

Check out the top three areas of compliance that your biotechnology firm should be aware of:

  • PCI Compliance

The Payment Card Industry Data Security Standard (PCI DSS) is a collection of regulatory security standards designed to ensure that all companies who accept, process, store, or transmit credit card data maintain a secure environment in which to do so.

The Payment Card Industry Security Standards Council (PCI SSC) was launched in September 2006 and is tasked with managing the ongoing evolution of the PCI DSS. The PCI SSC oversees the implementation of PCI DSS standards and works to ensure that all covered entities enforce compliance and maintain a secure environment for the processing of payments and credit card data.

  • HIPAA Compliance

The Health Insurance Portability and Accountability Act (HIPAA) is the regulatory standard framework for sensitive patient data protection. Any entities that deal with protected health information (PHI) must have a physical, network, and process security measures in place to ensure HIPAA compliance.

Covered entities and business associates (all third-parties who have access to patient information) must uphold HIPAA regulatory compliance and ensure that any additional subcontractors or businesses understand compliance requirements as well.

  • GDPR Compliance

The General Data Protection Regulation is a new compliance framework that requires businesses to protect the personal data and privacy of EU citizens for transactions that occur within EU member states.

The European Parliament adopted the GDPR in April 2016, and it officially took effect in May 2018. The mandate comes as a replacement for an outdated data protection directive from 1995. It carries provisions that require businesses to proactively protect personal data and privacy of EU citizens for transactions that occur within EU member states as well as regulating the exportation of personal data outside the EU.

Additionally, it must be noted that these are simply the three most common and wide-reaching compliance bodies that your biotechnology firm should be in tune with. Depending on the nature and extent of your organization’s data collection requirements, there may be other compliance standards for you to consider. Be sure to do your research or connect with a professional IT consultant in Silicon Valley to ensure you’ve got all your compliance bases covered.

  1. What are the best strategies for mitigating cybersecurity risks?

Simply put, the best strategies for cybersecurity in biotechnology will incorporate people, processes, and technology. Even with the most hi-tech security solutions in place, a truly comprehensive cybersecurity strategy for biotechnology professionals will include a dynamic and layered approach that makes considerations for your team and the processes they follow.

The fact of the matter is, cybercriminals always seem to be one step ahead. Therefore, it’s critical that your cybersecurity strategy is comprehensive, proactive and well thought-out. This means implementing proactive strategies for mitigating risk as well as responsive strategies that will help your team effectively respond in the worst-case scenario.

A proactive and dynamic cybersecurity plan for biotechnology professionals will include:

  • A detailed vision and strategy for mitigating risk and protecting data
  • A strong, strategic, and reliable IT leadership team
  • Effective and enterprise-grade IT infrastructure and resources
  • Continual end-user training and knowledge sharing
  • Robust disaster recovery and business continuity strategies

Using a bottom-up approach, your Silicon Valley biotechnology firm should work to ensure every member of your team – at every level – understands the importance of remaining secure and compliant. This means connecting your team with the knowledge, resources, and strategic planning they require to remain vigilant and secure.

  1. What should our business continuity strategy consist of?

As mentioned, cybersecurity for Silicon Valley biotechnology firms isn’t just about proactive mitigation of threats. Unfortunately, attacks happen. In light of this reality, your firm must have a concrete plan for responding to a disaster. Without a strategic plan for rebounding and restoring operational data quickly, your firm could face devastating downtime, bad press, and regulatory penalty.

That’s why business continuity planning for biotechnology firms is so critical. By developing a detailed plan, your team will have a reliable guideline for how to respond effectively, efficiently, and ethically in the worst-case scenario.

A reliable and comprehensive business continuity plan for biotechnology professionals will include:

  • The implementation of data back-ups – preferably in more than one location
  • A regular backup schedule and backup testing schedule
  • Detailed and step-by-step instructions for responding to disasters
  • Regularly scheduled mock-disaster training for employees
  • Detailed lists of compliance responsibilities including breach notification requirements

Basically, your business continuity plan should serve as a form of insurance. It should be proactively designed to help you and your team respond quickly and carefully in the case of cyber hack or technology failure. Your business continuity plan should be on-hand and ready to be implemented whenever you need it.

  1. Is there professional IT security & compliance support for Silicon Valley biotech professionals?

The short answer to this question is, yes – there is definitely IT support for Silicon Valley biotechnology firms. In fact, a connection with the right IT leadership can greatly increase your chances of mitigating attacks and can also improve your ability to respond to any attacks that do infiltrate your system.

Many biotechnology professionals may not want to make the time and capital investments necessary to partner with a professional IT consultant in the Silicon Valley. However, these initial investments are peanuts compared to the potential costs associated with an unexpected breach or compliance pitfall.

Taking the time to seek out professional assistance will be a huge asset to your Silicon Valley biotechnology firm. Maybe you’re an application developer looking for compliance support in Cupertino. Or perhaps you’re a device innovator looking for virus protection in Sunnyvale. Who knows, you could be a biotechnology innovator looking for business continuity planning in Mountain Valley. Regardless of your needs or where you’re located in Silicon Valley, the right IT professional could make a world of difference in your cybersecurity effort.

Pulling the Trigger: Finding Ideal IT Security & Compliance Support for Your Silicon Valley Biotech Firm

As mentioned, the nature and extent of your biotechnology business doesn’t matter. IT security, data protection, compliance, and business continuity planning are must-haves for all life sciences professionals in the Silicon Valley. Without them, you leave your consumer data and company livelihood exposed to major risk.

Finding the right consultant doesn’t have to be impossible either. Determine the specific needs of your firm and do your research. Inquire with other Silicon Valley biotech professionals and see what they’re doing to remain secure and compliant. Compare different Silicon Valley IT professionals. At the end of the day, the right IT consultant for Silicon Valley biotech firms will be ready to customize their services to keep you more secure and prepared than you thought possible.

When in doubt, reach out to providers for some one-on-one consultation. Sometimes chatting with a professional can go a long way in terms of determining your specific needs and laying out a strategic plan for security and compliance. Check in with professionals who have experience providing IT support for biotechnology professionals. An experienced insider can make all the difference in the effort to secure your firm’s IT infrastructure.

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