FLOWBIT®
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FLOWBIT®, LLC 2012 - 21©
TERMS, PRIVACY POLICY
ENTERPRISE
CLOUD





// PLATFORM. APPLICATIONS. GOVERNANCE.
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CLOUD SERVICES
CLOUD TECH OPTIONS
SERVICE VENDORS
APP ARCHITECTURE
INTEROPERABILITY
ANALYTICS & MONITORING
TRUST & PRIVACY
UNDERSTANDING RISK
CYBER SECURITY
Overview

Flowbit helps organizations build patient-centric cloud systems within Quality Systems frameworks. That means providing solutions that enable and engage patients, healthcare providers, and their support networks in a regulatory-compliant manner. Our healthcare solutions implement widely accepted industry protocols and data formats to enable data flow integration and analysis, giving powerful insights into patient health and important business KPIs.









DESIGN. ENGINEER. DELIVER.
2012 - 21©
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PLATFORM










ON-PREMISE, IAAS, PAAS & SAAS
CLOUD TECH OPTIONS

As a medical device developer, you have options for providing a server infrastructure for your SaMD solution. These include your own on-premise cloud vs. trusted external IaaS, PaaS, and SaaS services.


SAAS

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SOFTWARE AS A SERVICE

SaaS is easy to get started as you only need to pay for access to the software through a user account provided by the SaaS company. Most services allow you to access the software from anywhere — think Google Docs, MS Office 360, DropBox, etc.
PAAS

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PLATFORM AS A SERVICE

PaaS allows a company to develop its business functions on a platform that is already built. The management of the servers, operating system, and application runtime environment is provided for you— think Google App Engine, Red Hat OpenShift etc.
IAAS

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INFRASTRUCTURE AS A SERVICE

IaaS provides you with a virtual scalable data center. You are essentially renting computer servers from the provider and have the flexibility of installing your custom software on them — think Amazon Web Services or Google Cloud Platform.
Cloud Computing Options Include IAAS, PAAS, and SAAS

Your solution may combine or utilize some aspects of these listed offerings. For example, the configuration needs for a device developer who utilizes cutting-edge AI solutions and relies on a specific version of OS and 3rd Party software, may be better suited for an IaaS solution combined with a SaaS that provides a database service. In contrast, a cost constrained project may rely more exclusively on PaaS or SaaS.
FLOWBIT® will match you with the right combination of cloud and on-premise Healthcare IT solutions.




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AWS, GCP, AZURE
SERVICE VENDORS

Many Trusted Cloud service providers have services that include data ingestion, storage and work management solutions. Major Cloud Service Providers - such as MS Azure, Amazon Web Services, and Google Cloud - have compelling healthcare IT services. These are widely trusted, certified and compliant with regulations that conform with HIPAA, HITRUST, FedRAMP, ISO27001, ISO27017, ISO27018, and 21 CFR Part 11.





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AMAZON WEB SERVICES

Amazon Web Service (AWS) is one of the world-leading cloud service providers. Their infrastructure services and solutions include application servers, databases, data lakes, analytics, and Internet of Things (IoT). AWS has physically separated server locations, allowing for redundancy, low latency, and fault tolerance in your system. The AWS infrastructure is built to satisfy the most risk-sensitive organizations. Flowbit specializes in many AWS technologies to help you build software on this platform.

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MICROSOFT AZURE

Azure is Microsoft cloud computing platform, and is the first choice of many established enterprises. Many organizations that are already invested in Microsoft technologies such .NET and C# will find this computing platform to be a natural fit. Microsoft Azure adheres to strict compliance and regulatory requirements to satisfy data privacy and security concerns. Flowbit can help you build your mission critical applications using this very reliable platform.

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GOOGLE CLOUD PLATFORM

Google is considered one of the leaders in Cloud AI Developer Services. They provide enterprise-grade integration with TensorFlow AI/ML platform. This is a great choice if you are already utilizing TensorFlow-related workflows and technologies. Backed by Google’s distributed datacenters and global presence, GCP offers best-in-class cyber-security, as well as massive and elastic scaling options. Flowbit helps you configure your IT infrastructure on this capable platform, so you can focus on your core competency.




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APPS









DATA INGESTION, WORKFLOWS, MONITORING, SHARING
APP ARCHITECTURE

Flowbit’s approach to application development can help integrate your digital health application solutions into your existing enterprise infrastructure, and also give you an interface from which to extend and integrate. For Connected & Digital Health cloud applications, we typically require data ingestion followed by data transformation, storage, auditing, and sharing de-identified data within regulation requirements and with trusted and authorized partners. Due to regulatory requirements for carefully and responsibly managing patient's sensitive data, we need to avoid a monolith approach to designing applications, enforce data segregation, and process data within relevant trusted and authorized boundaries.





Enterprise applications are mostly independent but must interoperate in order to produce systems that can accomplish goals and function holistically. In some cases, we have to integrate applications that were not designed with any integration in mind. However, Flowbit applies best practices and tested design patterns that address the many types of challenges in designing for enterprise architecture.



FLOWBIT® utilizes many established design patterns and best practices for solving healthcare enterprise architecture challenges.





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UTILIZING DOMINANT STANDARDS
INTEROPERABILITY

Systems that share meaningful data with each other can encourage collaboration between researchers, care providers, and patients— promoting clinical operations quality improvement, enhancing patient engagement, facilitating cutting edge research, and ultimately improving patient outcomes we need. To accomplish these and similar goals, the healthcare industry has a few dominant protocols and specifications including HL7v2, DICOM, and HL7v3 FHIR.



Data ingestion with HL7v2, DICOM, and HL7v3 FHIR APIs


FLOWBIT® helps you understand how these standards and protocols are used in different settings and helps you effectively integrate systems to meet your business goals – all while meeting regulatory requirements.




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DATA
GOVERNANCE









META-DATA & LOGGING
ANALYTICS & MONITORING

Flowbit helps you set up and integrate with a centralized Monitoring and Auditing system providing you not just project-based insights, but also a holistic view of activity throughout your enterprise. HIPAA requires that we monitor and audit Data Ingestion, Data Access and Data Sharing Activities. We employ best practices to help you implement an effective Monitoring and Auditing system capable of providing you with analytics and event notifications about system health.





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// DATA GOVERNANCE
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HIPAA, GDPR
PRIVACY

Flowbit performs due diligence in understanding privacy safeguards placed in the cloud systems — whether they be on-premise or off-site service providers. This is paramount to building trust with patients, device developers, researchers, and healthcare professionals. In addition, regulatory compliance standards, such as HIPAA in the US and GDPR in the EU, require that access to health data is restricted to healthcare employees who need to view health and personal information in order to provide healthcare services and perform administrative duties.


In the interest of improving patient health outcomes, enhancing patient engagement, performing longitudinal studies, improving clinical operational insights, and encouraging collaboration with researchers and care providers, we need systems that can share meaningful and useful data with each other. As such, it is important to note that these regulations also allow for de-identified necessary data to be leveraged for secondary uses in certain cases.

FLOWBIT® helps you design ethical and regulatory-compliant workflows that allow you to utilize de-identified data for additional purposes.





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// DATA GOVERNANCE
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UNDERSTANDING THREATS
RISK ANALYSIS

The healthcare industry is plagued by myriad cybersecurity related issues, mainly due to the fact that healthcare data is very rich, often running on legacy systems. Ransom demands in 2020 averaged $4.8 million. These attacks included Distributed Denial of Service, Ransomware, Data Breaches, Insider threats among others.
Flowbit understands the paramount concerns around security for patient safety and business reputation. As a result, we perform comprehensive risk analyses and threat modeling to ensure you have the right tools to mitigate or eliminate any risks to your system— right from the early design phases of your project.







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MITIGATING THREATS
CYBER-SECURITY

Flowbit uses comprehensive checklists, tools, and procedures, including technical safeguards, such as identity and access control mechanisms, encryption at rest and transmission, and audit and activity logs. Beyond these, we work with you and 3rd party vendors to ensure you meet HIPAA and GDPR compliance standards by putting in place administrative and physical safeguards.



Cloud shared Security Model - An example model for IAAS Cloud System



An advantage of using Cloud services versus on-premise solutions is that with Cloud, many safeguards are already put in place by industry leading professionals and experts as part of the service at no extra cost.





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LEARN MORE

about designing for cloud computing, service vendors and application architecture options that enable interoperability, analytics and monitoring. Flowbit has expertise to help you design regulatory compliant systems including HIPAA that address cyber-security related concerns in current modern and effective ways. Leave us a question or comment.