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How to Ensure Data Protection, IT Security, and Compliance in Life Sciences

Taking a holistic approach to data protection shields organizations from cyber threats and ensures compliance with regulations.

Industry Perspectives

April 30, 2024

6 Min Read
clinician securely sharing sensitive healthcare data across mobile devices and medical practices

By Ravikumar Vallepu

The digital transformation of the healthcare and life sciences industry has revolutionized how providers access, process, and analyze data. The protection and security of data is vital, especially in the highly regulated life sciences and healthcare industries.

In 2023, approximately two healthcare data breaches of 500 or more records were reported each day, with 364,571 healthcare records on average breached daily. Although there has been a rapid increase in data breaches and numerous associated hard and soft costs, many healthcare and life sciences organizations struggle to meet basic security measures and don't consistently adhere to cybersecurity and compliance best practices. This may be due to budgetary pressures, lack of skilled talent, and failure to implement a holistic approach to data protection, security, and compliance.

Data privacy regulations, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States, the General Data Protection Regulation (GDPR) in the European Union, the California Consumer Privacy Act (CCP), and Brazil's General Personal Data Protection Act (LGPD), underscore the need for organizations to be prepared and compliant. It is no longer sufficient to simply have security measures in place — a comprehensive and integrated approach to data protection is essential. 

Related:How Healthcare Giant Uses Data Storage Tiers for PBs of Data

Foundations of Safeguarding Healthcare and Life Sciences Data

A holistic approach to safeguarding data helps protect organizations from cyberattacks, meet regulatory requirements, and avoid hefty fines. Additionally, it builds trust with stakeholders, protects organizational reputation, and delivers exceptional customer experiences. A holistic data protection plan focuses on:

  • Data encryption. Encryption is crucial to protect sensitive data in the life sciences industry, safeguarding patient or customer information, including banking or credit card information. To secure re-identification data, remove or modify direct identifiers such as names, addresses, and Social Security numbers, and consider changing to indirect identifiers like birth dates and ZIP codes. Additionally, anonymization and de-identification play a vital role in safeguarding data. While the GDPR favors anonymization, which is irreversible, HIPAA and California's CCPA require de-identification in many cases.

  • Access control. Access controls and anonymization safeguard individual privacy. Strict role-based access controls, multi-factor authentication, and regular access reviews ensure appropriate access to sensitive information, limiting those who can view, edit, or otherwise access healthcare data. Platforms that are single-sign-on (SSO) friendly are becoming increasingly popular and prevent passwords from being compromised. New and emerging technologies such as passwordless authentication using biometrics, patterns, tokens, or single-use passwords can significantly reduce the number of IT help desk tickets, saving time and resources.

  • Employee training and awareness. It is crucial to educate staff throughout the organization about best practices for handling sensitive data and recognizing and avoiding cyberthreats. Share policies, display visual aids, and provide training and phishing simulations to reinforce practices and create a security-centric culture. This environment helps minimize the risk of insider threats and human error that may compromise the security of organizational, patient, and customer data.

  • Secure infrastructure. Outsourcing IT infrastructure to major cloud providers such as Google, AWS, and Microsoft can improve organizational data security and compliance posture and provide additional security controls and backup capabilities. Additionally, larger cloud providers align their platforms with many leading regulatory bodies and security standards, supporting critical compliance requirements. Companies can also employ low- or no-cost security and data protection tools. For example, Microsoft 365 offers document encryption, data loss prevention, endpoint protection, threat detection, and antivirus tools. Some healthcare and life sciences organizations may prefer to host their IT infrastructure and tools on-premises based on cost, security concerns, or local and national government restrictions.

  • Regulatory compliance. It is essential for organizations to adhere to industry-specific regulations regarding data protection. According to Dieter Runge, co-founder and vice president of global growth and strategy at Boostlingo, "HIPAA is 100% the Bible for us when it comes to compliance." Boosetlingo contracts with external consultants to conduct regular security audits and penetration tests to ensure the security of internal company data and its IT platform. While HIPAA is Boostlingo's primary regulatory body, other organizations may need to consider additional regulations.

  • Data backup and recovery. It is vital for healthcare and life sciences companies to establish frequent and automatic backups of critical data. In addition to helping businesses recover from a ransomware attack, natural disaster, or other emergencies, many regulatory agencies require a comprehensive data backup and recovery system in certain scenarios.

  • Data sharing and ethical research standards. For organizations that collaborate with other entities for research purposes, it is crucial to have data-sharing agreements in place. These agreements establish protocols and standards and protect individual privacy through access controls and anonymization techniques. When conducting research studies, it is essential for participants to understand their privacy rights and be informed about what data will be collected, analyzed, and shared. To minimize the risk of unauthorized access or misuse of sensitive information, retain data only for as long as necessary and securely dispose of it when it is no longer needed.

  • Response plan. A well-defined data breach response plan ensures that organizations are prepared to handle breaches and minimize their impact. Create mitigation strategies for each scenario, analyze potential risks, and establish emergency preparedness guidelines. Also, identify the most critical industry-specific regulatory agency and follow its standards. Additional measures include obtaining SOC2, NIST, CIS, or ISO 27001 security credentials. In the event of a data breach, promptly assess the extent of the breach and take immediate action to mitigate further damage. This includes notifying affected individuals and providing them with guidance about how to protect themselves. Cooperate fully with regulatory authorities and provide all necessary information to aid their investigation.

There's Still Work to Do

Change Healthcare, a healthcare revenue and payment cycle management provider, was recently the victim of a ransomware attack that impacted providers, hospitals, pharmacies, and patients. The American Medical Association reports that the number of cyberattacks on U.S. hospitals and health systems more than doubled from 2016 to 2021; the healthcare sector saw an average of 1,684 attacks per week in the first quarter of 2023. Prioritizing security and privacy should be at the top of the list for any service provider, product maker, or firm that supplies technology to the health sciences industry. The most effective strategy is holistic, robust, ongoing, and ethical, and a bottom-line issue — creating trust.

About the Author:

Ravikumar Vallepu is a master data architect with more than 14 years of cross-cultural experience in technology consulting, digital transformations, process designs, and management of master data tools and platforms. Ravikumar is a champion with the ability to lead, manage, and deliver complex projects in the supply chain and enterprise data management (EDM) area using global delivery methods for medical, pharma, retail, agricultural, chemical, food and beverage, and biopharmaceutical enterprises. He holds a master's degree in computer science. For more information, contact [email protected].

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