Cloud computing technology continues to transform countless industries — including the medical device industry. Diagnostic devices, connected therapeutics, and digital health have all benefited from cloud connectivity, improving care for patients, and the bottom-line for device manufacturers. Cloud connectivity is not without risks though. Safely connecting devices to the cloud can be an incredibly time-consuming process, and poses critical regulatory and financial risks. Knowing these risks and mitigation strategies early in the development process is critical to commercial success.
The business case for cloud connectivity
The market for connected medical devices is stronger than ever and will continue to grow. New connected medical devices are making the news every day, but we are only beginning to see the benefits these devices will bring.
The ultimate goal of a connected medical device is to provide better care for patients — better outcomes, at a lower cost.
Cloud connectivity can be used to support remote patient monitoring, and patient compliance and outcome traceability. The use of the rich data collected by these devices, as well as the use of AI and advanced analytics, supports improved diagnosis and treatment across many categories of devices and patient populations.
From the perspective of the medical device maker, these capabilities offer a unique selling proposition when marketing their device(s) to patients and the medical community.
Additionally, having a cloud-connected device allows the manufacturer to remotely monitor the health of the device itself, and to serve firmware updates “over the top.”
Cybersecurity risks
Healthcare is an attractive target for hackers looking to extract ransom, as there is an incredible sense of urgency to get systems back up and running, quickly. According to Health IT Security, healthcare cybersecurity attacks doubled in 2020, with 28% of those occurrences being connected to ransomware.
Managing security requires embedding it as part of your company culture from the get-go. This spans from the design of the device to it becoming fully operational. You have to always think of the people who are the end-users of your device and how to keep them safe.
Security isn’t just something you think of once, or tack on at the end. It’s a cultural shift and a commitment for the entire lifecycle of the medical device.
With that being said, you obviously need to start somewhere, so where is a good place to begin?
- Create a set of cybersecurity procedures
- Analyze your risks and create mitigation strategies
- Train your workforce on good cybersecurity practices
- Ensure good engineering and operational practices
- Create and maintain proper access controls
- Data backups and disaster recovery
- Constant monitoring
Privacy risks:
Non-compliance of HIPAA regulations can result in penalties, either in the form of fines, jail time or both.
There is a common misconception that deploying your application on a “HIPAA-compliant” cloud infrastructure automatically confers compliance; however, the infrastructure is only the foundation. The application itself and surrounding procedures must also be as strong as that foundation to guarantee the safety of critical data.
Your application needs to be designed from the ground up with security as a top priority. Enforcing coding best practices, rigorous code reviews, and detailed, traceable requirements are just as critical to achieving (and maintaining) compliance with any privacy standard that you are being held to.
Build vs. buy
Building a cloud connectivity solution for medical devices that meets security and protection objectives requires a broad spectrum of expertise: technical, operational, and regulatory. Identifying and bringing in-house this expertise to build a custom solution is often beyond the ability, and/or resources, of many medical device companies.
Building a secure, compliant cloud requires technical, operational and regulatory expertise
When pursuing the “buy” option, identify a cloud connectivity partner with broad expertise and a clear understanding of security issues in both general cloud connectivity and medical devices. Protecting cloud storage and computing assets by itself is a daunting task, requiring deep expertise across several dimensions. The additional nuances of medical device data security narrow the field of qualified partners.
Here are some important questions to ask when choosing a cloud connectivity platform for your medical device:
- Is the solution compliant with privacy requirements and built by an ISO 13485:2016 certified company?
- Is the solution cloud-based and built on top of highly reliable, global infrastructure?
- Is the security robust and is it a fully managed solution?
- Is the platform built with your future in mind?
Risk of not having connectivity
Is cloud connectivity worth the investment?
While collecting data presents a significant risk, not doing so may create a greater risk. Though there are plenty of costs and risks associated with cloud connectivity, you cannot overlook the potential business impact of omitting connectivity from your roadmap.
“The Definitive Guide to Medical Device Connectivity,” offers in-depth guidance on device-to-cloud connectivity for medical device companies. The guide is co-authored by a team of leading experts in medical device design and development, who have a combined 50+ years of experience in healthcare technology, medical devices, and regulatory compliance.
About Galen Data
Galen Data, Inc. provides a turnkey cloud solution for medical device makers that is configurable, secure, and compliant. The company was founded to make device-to-cloud connectivity possible in a matter of weeks instead of months, and at a fraction of the cost. The Galen Cloud™ collects and securely stores data, and includes tools to visualize and analyze that data. Dashboards and alerts for the manufacturer, medical team, and patients are also provided within the platform. The Galen Cloud is compliant with FDA, HIPAA, and CE Mark standards, and is ISO 13485:2016 certified. Dozens of companies have partnered with Galen Data to solve their medical device connectivity needs.
