Does cloud CTMS hosting offer a real advantage over on-site solutions? With increasing market pressure and ever tightening budgets, clinical research organizations of every size are being driven to find new ways to efficiently manage clinical trial data. But with patient health and business success at risk, data security and regulatory compliance have to stay at the forefront.
Compliant cloud hosting providers, like ByteGrid, give medical device manufacturers a head start in ensuring device security. These companies are increasingly focused on cybersecurity, as yet another federal agency turns their eye toward their systems, looking for weak spots. Only a few weeks after the FDA's finalization of the Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, it was announced that the U.S. Department of Homeland Security is investigating possible cybersecurity flaws in medical devices.
ByteGrid is the leader in GxP compliant cloud hosting. Designed specifically for GxP compliance, we offer the secure infrastructure and well-documented supporting processes that the FDA requires for regulated computer systems.
The team at ByteGrid has been implementing and validating FDA-compliant computer systems for years. Our regulatory team has achieved FDA acceptance for medical device software and other GxP regulated computer systems for a multitude of platforms, including complex, networked systems.
Now that the FDA has finalized their Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, let's look at some of the ways GxP cloud hosting can help medical device manufacturers adhere to agency recommendations.
A HIPAA compliant cloud has a system of safeguards in place to protect ePHI. Advanced data encryption is a fundamental part of this system. If you're looking closely, you might notice that it's technically true that data encryption isn't defined as 'required' by HIPAA regulations, since it is an 'addressable' specification. But don't be fooled – if you're storing ePHI, encryption should be a part of your solution. Without it, you're far more likely to run afoul of the regulations, and your business could suffer for it.
HIPAA compliant hosting, when done properly, can help protect you from serious compliance violations. Take, for example, the breach that resulted in the largest HIPAA settlement to date.
This May, New York and Presbyterian Hospital and Columbia University paid a settlement of $4.8 million, combined. This is largest settlement amount with the OCR for a HIPAA violation so far.
ByteGrid offers IT solutions that are as close to plug and play compliance as you can get.
If you're a covered entity, there's no getting around the specific requirements for you and your staff, things like training and documented procedures for how PHI is handled at your company. The system starts and ends with you, and you'll need to make sure that things are in order at your office. But more and more, the majority of the compliance burden is falling to IT, as the transition to electronic health records becomes nearly universal. Partnering with a HIPAA compliant hosting provider helps you achieve a fully compliant solution without overburdening your existing staff.
HIPAA compliant cloud hosting is a cost-effective way for healthcare companies and their business associates to manage increasingly complex IT systems. At the same time, the threat of compliance failures are all too real. What's actually best for your business?
HIPAA compliant cloud hosting ensures that vital healthcare data is available whenever and wherever you need it. However, there's a lingering perception that the cloud is a compliance risk, especially in the face of high profile, large scale security flaws like Heartbleed and the recent Internet Explorer bug. The risks associated with a security breach are real, but by taking the right steps, covered entities and their business associates can ensure that they're fully protected.
Choosing a datacenter designed specifically for HIPAA compliant hosting is the fast track to compliance for your IT system. But how can you know you're choosing a compliant provider? Pouring over hundreds of pages of HIPAA regulations and figuring out how they relate to your specific situation can be daunting. Add the technical guidelines and you can quickly become overwhelmed, especially if you don't have a well-staffed IT and compliance team in-house. You need a way to manage this complexity.