In today’s medical device landscape, data is the foundation for innovation, better patient outcomes, and improved clinician efficiency. However, balancing the potential of data with strict privacy regulations and limited technical resources is a challenge that must be addressed. BioT’s newly introduced Regulatory-Aware Analytics Framework offers a groundbreaking solution that ensures your medical device cloud infrastructure stays fully compliant while you unlock the full potential of your data within your system—all without requiring deep technical expertise or isolated analysis/visualization platforms to do so.
BioT’s Regulatory-Aware Analytics allows companies to perform in-depth analyses of operational, clinical, and device data within a framework that ensures full compliance with privacy regulations like HIPAA and GDPR. Additionally, this framework ensures that your analytics environment is segregated from operational services, eliminating any risk of data loss or interference with live operations and performance.
A vital enabler to this capability is BioT’s unique NoCode/LowCode Developer Studio. In an industry where finding tech skills, domain knowledge, and available talent are a challenge, BioT democratizes analytics development and enables teams without specialized data science or coding expertise to create, customize, and manage their analytics workflows and dashboards. This foundational capability allows organizations, from startups to Tier 1 MedTech companies, to do more with fewer resources, reduce operational costs and speed up time-to-insight.
1. Regulatory-compliant Visualization and Dashboards
While generic tools like PowerBI or Tableau offer visualization capabilities, these don’t address the need for built-in regulatory compliance, which MedTech companies require to meet. With BioT, MedTech companies can create customized visualization, where the entire process remains compliant with stringent regulatory standards such as HIPAA and GDPR. This reduces the risk of using multiple platforms with various security vulnerabilities, and ensures all analytics stay under BioT’s certified operational controls. Clients also avoid additional external tools' costs, licensing fees, and cybersecurity risks when working across many platforms.
2. NoCode/LowCode Analytics and Data Structuring
BioT’s NoCode/LowCode Developer Studio democratizes analytics for all teams, even those without advanced technical skills. This enables teams to create and customize data workflows without requiring deep coding expertise, significantly reducing development costs while accelerating data-driven insights.
3. Postmarket Surveillance and Beyond
Postmarket Surveillance is an emerging regulatory requirement. BioT automates this process through its platform. Clients can easily monitor device performance in the field, assess risks, and integrate these insights into your Quality Management System (QMS). Additionally, by leveraging NoCode/LowCode analytics, teams can rapidly adapt and tailor their monitoring schemes to detect emerging risks, ensuring regulatory obligations are met efficiently.
4. Data Privacy and Compliance Built-in
The analytics framework is designed to manage precisely any sensitive health data (Protected Health Information, or PHI). Every piece of data is subject to attribute-based controls, allowing access to be tailored down to individual data fields within any entity in your data model. This ensures complete control and privacy adherence, even when using external tools like AI training systems or other BI Tools.
5. Certified Operational Controls and Documentation
One of the key advantages of BioT’s platform is that all data analytics, data management, and visualization capabilities are integrated within BioT’s certified operational controls. This allows MedTech companies to dramatically reduce risk and shorten the time to comply with healthcare systems and regulators requirements and standards. Companies can streamline compliance efforts by keeping everything under BioT’s certified infrastructure, avoiding the additional overhead of managing multiple external platforms and their associated regulatory burdens.
6. Complete Data Segregation
BioT’s platform distinguishes between operational databases (for real-time data) and the analytical environment under our microservices-based architecture. This separation prevents resource-intensive analytics from disrupting ongoing services, ensuring the smooth performance of your cloud-powered devices.
BioT’s Regulatory-Aware Analytics can drive new revenue streams. With strict privacy controls, clients can safely share and monetize data with partners without compromising security.
BioT’s Regulatory-Aware Analytics is designed to meet today’s compliance-heavy environment but is also built for the future. As a constantly improving platform that includes continuous compliance updates, PHI management, and postmarket surveillance tools, BioT ensures that your analytics remain robust and compliant with evolving standards.
BioT’s Regulatory-Aware Analytics is more than just a compliance solution—it’s a powerful enabler of innovation. By providing NoCode/LowCode Developer Studio, integrated visualization, and complete regulatory documentation, BioT allows medical device companies to unlock the full potential of their data while staying compliant with the world’s strictest regulatory standards—all under one secure, certified infrastructure.
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Last updated on:
August 1st , 2024 VER .17