The digital revolution promised to change the way we handle medical information management, yet it also posed immediate challenges regarding security, privacy, and confidentiality. Today, Medical Affairs teams must balance regulatory demands for healthcare information security with the need to make data sufficiently interoperable and accessible to generate meaningful insights.
Choosing tools with robust onboard security offerings, like Anju’s IRMS MAX, can help Medical Affairs teams balance information-sharing with the need to comply with regulatory demands for security and confidentiality.
Securing Medical Information Without Sacrificing Access
The balance between security and accessibility has remained a significant concern in healthcare, particularly as the use of electronic health records has increased. As early as 2010, researchers Julia Lane and Claudia Schur recommended the use of remote “data enclaves” to protect medical information — an approach taken today in the form of cloud computing and web-accessible platforms.
Today, expressions of the issues associated with security and access take various forms. The U.S. Department of Health and Human Services, in its guide to assessing information security in small clinics, notes the need to balance confidentiality, accessibility, and data integrity — protecting data from alteration or deletion by unauthorized persons.
Physical, technical, and administrative strategies can all be employed to secure medical information while still protecting necessary access, write Nduma N. Basil and fellow authors in a 2022 article in Cureus. Physical strategies include securing devices like servers in restricted spaces, while administrative strategies include policies and procedures for generating, storing, and accessing protected information. Technical safeguards focus on software, like platforms and encryption tools, to protect digital information.
Basil et al. recommend emphasizing technical safeguards like firewalls, data encryption, antivirus software, and cloud computing. They note that “technical safeguards are essential as most security breaches occur through electronic media such as computers and mobile phones.” By emphasizing technical safeguards through careful choices of systems and other tools, Medical Affairs teams can strike a balance between protecting medical information effectively and accessing it when needed.
How IRMS Max Helps Teams With Medical Information Management
When transitions to electronic medical records, trial master files, and similar medical information began in the late 2000s and early 2010s, many life sciences organizations faced the issue of whether to start their efforts from scratch. Today, organizations do not need to build bespoke servers or systems to protect information — or to balance security needs with accessibility concerns.
Instead, Medical Affairs teams can rely on tools like Anju’s IRMS MAX. IRMS MAX is an end-to-end adaptable Medical Affairs solution, allowing teams to collect information, maintain security and privacy, and share vital insights — delivering the right information to the right audience at the right time.
Features that support balancing security and accessibility in medical information management include:
- Data Encryption. Personal information entered into IRMS MAX can be encrypted or deleted as defined by the system’s administrator at the database ensuring that users’ information is protected while allowing for the successful processing of inquiries. This function can also be used on demand to meet “right to be forgotten” requirements.
- Security Groups – IRMS MAX users can be restricted within the application so that permissions to customer information can be limited to only those users who need access.
- “Division” to manage the scale of deployments. Perform local, regional, or global-scale deployments with the “Division” feature, which allows for configuration without sacrificing security, data protection, or compliance.
- Centralized case intake provides a single, protected source of information. The Adverse Event and Product Complaint modules create a single source information intake, protected throughout its journey — from initial intake to transmission to safety and complaint systems.
- Integration without exposure. Anju BUS is purpose-built to connect IRMS MAX to other systems, such as a CRM and other existing applications, allowing for necessary data access and transfer without exposing data to unauthorized parties.
Digital information tools make medical information collection and analysis easier than ever, but they also pose challenges in maintaining security and accessibility. With tools like IRMS MAX, Medical Affairs teams can strike this balance.
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Authored by John Ferguson, VP of Product Management for Medical Affairs
John Ferguson, VP of Product Management for Medical Affairs at Anju Software, boasts over 15 years of experience, holding various titles such as business analyst and director. In his role, he oversees project management and software implementation for global pharmaceutical companies, ensuring seamless integration and optimal performance. With a background in finance and an MBA from DePaul University, John’s dedication to continuous improvement drives innovation and success in the medical affairs sector. Connect with John on LinkedIn to explore his achievements further.