Medical devices are becoming one of the most rapidly developing healthcare spheres, with more than 50 new models and patents approved by the FDA annually (source).
As for the financial side, the global medical devices market is expected to reach $612 billion by 2025 (source).
Unfortunately, apart from great profits, this sphere creates additional challenges for healthcare organizations. Strict medical device regulations, imposed by governmental and international entities, set many requirements for healthcare providers designing or applying medical devices. Organizations also have to process immense loads of medical device data. It requires them to exploit significant server capacities, use complex medical device data management systems, and leverage cloud computing for scalable databases.
Optimization of critical data management becomes a solution for healthcare providers that struggle with such issues.
If you are also drowning in tons of disparate medical device data, we know how to help you. Read our article to learn how to improve critical data management in medical devices .
What is critical data and why it's important?
Before we dive into the technology domain, let’s discuss the concept of critical data. There is no universal critical data definition, but, generally, this concept refers to essential data sets defining the professional practices of an organization. Critical data elements vary according to the industry. When it comes to critical data from medical devices, it may include:
- patient health parameters
- medical device settings and information on its state
- general patient data stored on digitized medical devices
- automatically-generated patient statistics
The most valuable thing about such information is that it can completely regulate the workflows of medical organizations in the modern data-driven world. Critical data from medical devices defines patient approaches taken by healthcare practitioners.
Suppose you are a healthcare practitioner. Information from medical devices allows you to overview a patient’s state and indicate any changes in it. It also gives you a better understanding of a patient’s condition. The more you know, the higher are your chances to develop more efficient strategies for individual patient care.
Meanwhile, the loss of critical data elements can bring healthcare businesses big problems, including legal disputes. It is especially relevant when it comes to patient health information protected by various governmental and international regulations.
Learn how FHIR helps introduce interoperability in digital solutions
Reach Interoperability in Healthcare Solutions
Learn how FHIR helps introduce interoperability in digital solutions
How to improve critical data management for medical devices
What should a healthcare organization do to avoid problems with critical data from medical devices? Our recommended solution is simple: go for data management optimization. Here is the checklist of tips that will help a healthcare provider enhance its critical medical device data management practices.
1. Implement clear data architecture
Medical devices provide healthcare organizations with immense data loads that require a well-thought and properly-structured approach to their storage and process integration. Data architecture becomes a starting point in critical medical device data management.
Here are the steps you will need to take for developing data architecture:
- At first, you have to decide the basic principles of data collection, integration, processing, storage, and use. The best solution is to rely on an experienced data architect who will develop the basics of smooth data management infrastructure. At this stage, you should establish the connectivity of medical devices to health management systems through secure information exchange channels.
- The next step requires you to choose between cloud-based and on-premise software solutions for the storage and processing of the retrieved data. You should also establish clear data processing principles.
- At the final step, which is often overlooked by healthcare providers, you will need to specify clear criteria for the classification of critical and unnecessary data. It helps make your data management practices more efficient. You will avoid information overloads and understand where the essential data is stored
2. Embrace end-to-end traceability
Data on the state and settings of wireless medical devices is critical for their medical device data management. When it comes to controlling such devices, a widespread solution is assigning a unique identification code to any medical device component, from raw material to a completed part. Such identification allows tracking this component at any given time. The end-to-end traceability system will provide data on whether a device or its component has been stolen, damaged, or diverted. Such a system can also store and transmit critical data on medical device settings and current state. Software enhancing end-to-end traceability will provide you with a much higher level of control over wireless medical devices. It implies the improved efficiency of data storage, processing, and integration.
3. Apply master data management platforms
The concept of Master Data overlaps with critical data because both refer to data points that are essential for an organization. Information from medical devices, which includes private patient data, falls into this category. Healthcare organizations should apply Master Data Management (MDM) platforms to administrate critical information from medical devices. MDM software provides solutions to some of your biggest pains. For example, you can use Master Data Management apps for recording, organizing, analyzing, and distributing critical data. Check the main benefits of Master Data Management platforms below.
4. Ensure smooth data integration
The essential point about managing critical data elements is to make your data “work.” It means developing smooth connectivity between medical devices and software required for critical data processing. All information has to be extracted, converted, and visualized on demand to provide maximum advantage to healthcare professionals. The key point is to avoid storing critical data elements in disparate places and situations when significant sets of information remain idle. Healthcare practitioners should have an opportunity to instantly retrieve the required critical data elements once they are needed.
5. Promote security and regulatory compliance
Medical devices' security is a must when it comes to managing healthcare critical data. Confidential information from medical devices is covered by multiple HSS regulations. Violation of such principles can bring a corporation a remarkable fine, which may reach up to $1.5 million per year. HIPAA rules established to protect patient private data are among the most significant HSS regulations.
Therefore, the use of HIPAA-compliant software for medical device data processing is the best way to ensure compliance with regulations on critical medical device data management practices. Where can you get such software for critical data operations? An optimum choice is to rely on developers with solid expertise in building HIPAA-compliant software. Experienced software engineers have to build your application in three consecutive steps. At first, the developers analyze all security requirements and identify potential risks according to medical device regulation principles. During the second step, they eliminate all the identified risks. The final step incorporates continuous administration and maintenance of your application’s safeguards listed below.
Attentiveness to such details will help you ensure the most secure critical data management practices.
The use of wireless medical devices makes healthcare providers face multiple data management challenges. To solve them, they need to secure and separate critical data. A comprehensive data management strategy based on up-to-date technologies can help with this.
Surely, even the most well-thought data management best practices are nothing without the required technology expertise.
That’s why Binariks is ready to become your helping hand in critical data management. We can create your data management architecture and fortify data-driven software following the most relevant regulations. Our specialists also create apps ensuring end-to-end traceability, master medical device data management, and smooth data integration. We have significant expertise in the healthcare industry, along with other technology domains.
Contact us to discuss your needs and take your critical data management practices to a new level.
Why Switch to the EPIC Cloud for Healthcare Providers?Jun 14, 2022 · 7 min read · Ross Chornyy
EHR Certification: Understanding Requirements and ProcessOct 6, 2022 · 11 min read · Liliya Kostetska