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HIPAA Regulated Companies: Your IT Partner Matters More Than You Think
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager : Feb 22, 2012
Health IT is a diverse and growing field which presents new challenges to both the healthcare provider, the IT shop and the consumer. Determining the correct blend of technology and patient safety is a difficult undertaking that requires a thoughtful and knowledgable team. Sidus BioData's regulatory advisors have over 25 years combined experience in the Health Sciences. We are unique among our peers in our ability to provide both technical and software solutions to our HIPAA regulated customers.
Find out more at www.sidusbiodata.com
Validated Hosting: Us versus Them
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager: Dec 20, 2011
Are you looking for space, processing powering, uptime, elasticity, security, data integrity, and regulatory accountability and compliance? If so, you should starting looking for a TRUE validated cloud hosting provider. Unless you work for GE it's pretty unlikely that you'll be able to convince Amazon or Google to qualify their hardware and systems for HIPAA/HITECH or FDA Compliance. Will they sign a business associate agreement?  Unlikely. Further, it's highly improbable that they’d support you in time of an audit.  Amazon and Google offer great services but they are simply not tailored to the regulated industries. For about the same price, you can enjoy all of the benefits of an Amazon or Google while also enjoying peace of mind.  Sidus BioData has invested the time and resources to fully qualify their Datacenter and Cloud while creating an EHNAC audited Quality System that is second to none. Â
Look no further for a validated hosting provider – Sidus Biodata is the key to peace of mind.
To learn more please visit http://biodata.sidusdata.com/
Regulated Hosting: Questions and Answers Session with Stephen Ferrell - GAMP Special Interest Chairman.
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager : Oct 26, 2011
Hosting was once the domain of websites, poetry blogs, and small businesses. In the last 10 years the industry has taken hold and an outsourced infrastructure is now the norm for corporations big and small, local and global. The added burden placed on companies regulated by 21 CFR Part 11, Annex 11 and the associated GMP’s, has caused many to shy away from Compliant Hosting. I recently had the opportunity to discuss this topic with Stephen Ferrell. Stephen is the outgoing chair of the GAMP IT Infrastructure Special Interest Group, he leads the V&V group for a local BioTech company, and he supports Sidus BioData as a Regulatory Advisor.
Say Goodbye to Validation and Hardware Costs
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager: Oct 10, 2011
Whether you are an established biotech, pharmaceutical or medical device manufacturer or are simply getting your feet wet, it’s inevitable that your business will need some combination of the following systems:
The Biotech Industry Should Better Understand the Consequences of a non-Validated Computer System
By This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Business Development Manager: Sept. 09, 2011
If you are a Medical Device developer, a Biotech firm or Pharm
aceutical Manufacturer, you are required to follow either 21 CFR Part(s) 210 & 211 or 21 CFR part 820. In tandem with 21 CFR Part 11, all of the computer systems used to support your manufacturing and design processes require validation. Often manufacturers make the mistake of attempting to claim that their computer systems are purely reference tools and that paper reigns. This approach has the potential to mislead, confuse and ultimately break the law. There are several citations issued by FDA including:
“Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 C.F.R. §820.70(i) (Production and Process Controls - Automated Processes).”
Quality Regulated Hosting - a simplified approach to data security and compliance services for the Life Sciences Industry.
When 21 CFR Part 11 was introduced in 1997, it created in equal measure - confusion and consultants. Fourteen years on, the confusion has largely disappeared and while regulation remains under review the chances of wholesale changes are highly unlikely. The cottage industry of consultants remains though, eager to serve for three months and leave a pile of validation protocols in their wake. While there are many competent hardworking consultants out there, there are many yet, who by virtue of their profession, have never sat in front of FDA or EMEA, have never had to defend last weeks, last month, or last years validation package.
The Greater Good
A few weeks ago, Sidus BioData exhibited at the National Hospice and Palliative Care Organization’s Leadership Conference in Washington DC. There I was, telling every person that walked by the story about how Sidus helped Hospice of the Chesapeake (HOC) eliminate their IT infrastructure and move their operations to a private cloud in our HIPAA Regulated Annapolis-based Datacenter. I told them that they, too, could get rid of their servers and make the move to the cloud and discussed how money could be saved by moving from an unpredictable capex model to a predictable opex model. The response…you guessed it…almost everyone looked at me with the same blank expression and either asked me to explain what cloud hosting was, or just took my free mints, my one page handout and kept on walking.
What Makes a Compliant Data Center?
Simply put, a compliant data center is a data center that conforms to a set of regulatory rules, specifications, standards or laws. Conforming to mandated laws or standards to meet federal and commercial regulations requires a considerable investment in, infrastructure, personnel and services. However, due to the significant cost, many commercial or private data centers have not made the proper investment in the physical, environmental and operational controls and services to meet t
he minimum regulatory requirements.
The most regulatory requirements map to industry best practices:
- Redundant Power and Cooling
- Intrusion Detection
- 24x7x365 Monitoring and Staff
- Backups and Documented Policy and Procedures
This is just the start, here is an example of a Compliant Data Ceter
IT security and Information Assurance professionals tasked with ensuring their information systems meet compliance requirements, have limited options when it comes to selecting a compliant data center.
Compliant Hosting for HIPAA and HITECH – Making the right choice.
These days, it isn’t hard to find a datacenter claiming “HIPAA Hosting” or “HITECH Hosting.” What is hard to find is a datacenter that truly understands and adheres to the guidelines surrounding HIPAA compliance. The exception, is Sidus BioData. Our datacenter is in full compliance with all health data regulations – we have a regulatory roadmap and quality manual to prove it, something I can say with certainty (because I have done my homework) that most others do not.
Read more: Compliant Hosting for HIPAA and HITECH – Making the right choice.
Outsource Solutions for HIPAA Compliance
Last February, President Obama signed into law the $19.2 billion Health Information Technology for Economic and Clinical Health (HITECH) Act to accelerate the process of digitizing electronic health records (EHR) in the United States. Under this law, hospitals and healthcare professionals who demonstrate “meaningful use” of a certified EHR by the year 2015 will become eligible to receive millions of federal dollars in incentive payments, and those who do not comply could be penalized. In addition, healthcare organizations must comply with related security and privacy requirements. This has proven both a powerful motivator and source of great concern for many healthcare professionals across the country. Â
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