With the deadline for complying with HIPAA Omnibus Rule requirements now behind us, it's time to look ahead.Compliant cloud hosting can keep you aligned with HIPAA regulations in the face of new legal challenges. Here's a look at what to expect for 2014.
HIPAA compliant hosting has so many benefits, its no wonder that healthcare companies are are turning to this platform for their data management needs.
The search for a partner can be daunting, though. Your first search could return a unmanageably long list of data centers claiming to offer HIPAA compliant hosting. But while a company may market themselves as HIPAA compliant, very few can make this claim truthfully.
SaaS hosting allows you to run leaner and faster when deploying your application, making it an increasingly popular way to market software products.
You are a Software Development house, for the last few years you've been providing superior software to the GxP regulated Life Science community. You've jumped over all of the regulatory hurdles, built 21 CFR Part 11 configurable signature and audit trails into your applications. GxP compliance is in your DNA, but more and more your customers are drifting from the traditional bricks and mortar server architecture. They're trimming their physical spaces, reducing their IT headcount and somewhere, out of nowhere, an Executive wants everything in the cloud and they want it yesterday.
Traditionally, Part 11 regulated companies have not used third party providers to host applications and data because it was believed that they could not meet privacy laws, security concerns, audit transparency requirements and they simply did not operate an adequate quality system with documented policies and procedures to satisfy compliance for 21 CFR part 11 hosting. This is still true of the majority of datacenters in the marketplace so vendor selection is very important to successful outsourcing.
While 21 CFR Part 11 and EUDRALEX Volume 4. Annex 11 are not substantively different, there continues to be a concern that compliance to one or both is not feasible in a Cloud based environment. At ByteGrid we share no such concerns, whether you are a SaaS or PaaS provider or a Life Sciences company in need of infrastructure, our fully qualified data center and cloud solutions meet and exceed the validation provisions of both 21 CFR part 11 and Annex 11. Our turn key Compliant Cloud offerings allow peace of mind for our customers allowing them to focus on their core business objectives. We are fully transparent and auditor friendly, now with over 50 policies, SOP’s and Form’s our Quality Management System is unique in the industry. Our client base includes CRO’s, Medical Device Manufacturers, Pharmaceutical companies, Biotech’s and SaaS providers.
The Cloud is now longer a buzzword, it's a byword. It's not something novel or new, it's an expectation from your customers, and if you are planning on staying competitive, it is a necessity. In the regulated world, there are a number of considerations when choosing a hosting partner – and finding one that is compliant with 21 CFR Part 11 is not so easy.
ByteGrid will be exhibiting at HIMSS13 Conference next month March 3-7 in New Orleans, Louisiana. Twelve workshop sessions will focus on Mobile Health – a hot industry topic in 2013. Mobile technology undoubtedly has many advantages to connecting patients to their caregivers and can even enhance healthcare related outcomes. However, this growing technology also presents security, privacy and compliance concerns that shouldn’t be overlooked. With the upswing in HIPAA HITECH fines, mobile technology breeches are sure to present concerns as they become increasingly, developed and accepted in this sector.
As a sign of what is to come the world of patient data regulation, it has been reported in the news recently that an Idaho Hospice paid a $50,000 settlement for a HIPAA breach. They failed to properly encrypt and protect electronic protected health information. (ePHI) This settlement adds to growing evidence that health care provider, and their business associates, need to carefully and appropriately manages their HIPAA HITECH encryption and other privacy and security responsibilities.
While at the AdvaMed Conference this past month in Boston, Massachusetts I was asked what makes our validated hosting different than other datacenters. At ByteGrid, three things drive the superiority of our solution: