There are two competing ideas when it comes to being a compliance officer in a biotech firm. One perception is that it’s a very boring position. The other says that being a biotech compliance officer is akin to riding a bike down the freeway with your hair on fire.Speak With KalioTek™'s Compliance Team
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There are two competing ideas when it comes to being a compliance officer in a biotech firm. One perception is that it’s a very boring position. The other says that being a biotech compliance officer is akin to riding a bike down the freeway with your hair on fire.
The truth is somewhere between those two extremes.
Biotech compliance officers have to deal with industry and legislative compliance requirements along with the internal politics of their company. It’s never easy, and it’s seldom boring.
One thing is true, however.
Compliance is always complicated – especially where compliance makes demands of your company’s IT setup, daily function, and protocols.
That’s where a team like KalioTek™ can leverage our biotech compliance service to help your compliance officer and aid your company in meeting the requirements of the FDA, HIPAA, GDPR, PCI DSS, and others.
While each executive and compliance officer has their reasons for wanting to invest in IT compliance consulting, here are a few of the more common reasons we hear.
Regulatory and industry-standards IT compliance boils down to five parts.
You already know that your business leverages massive amounts of data and that HHS or FDA have expectations as to the way that data is stored and handled.
You’re also already aware that your entire IT infrastructure has to be in line with their guidelines and that you must abide by a group of pre-set protocols.
What may not be immediately apparent is that IT compliance is not a “one and done” operation. Continual risk management is necessary because of the ongoing evolution of technology.
An IT compliance strategy consists of:
If your company does not have these four IT compliance strategy elements in place, you will not have peace of mind about potential audits or your security posture.
You are already aware of the U.S. Department of Health and Human Services and the Food and Drug Administration. Depending on what kind of work your company does – medical research, pharmacological research, agricultural research – you fall under one or both of these governmental agencies.
Here is a brief overview of the FDA and HHS as they relate to your biotech company.
The FDA – The FDA is in charge of keeping the food supply chain of the country safe and overseeing drug development and testing. The FDA’s mandate puts them responsible for companies involved in the following:
The FDA has two “manuals” of which you need to be aware.
These two manuals detail the minimum threshold expected of your company by the FDA. A company that hires an outside firm to deal with their IT compliance is looked upon more favorably by the FDA and is often well above the minimum expected threshold.
HHS – The Department of Health and Human Services is tasked with evaluating businesses and enforcing compliance with the Health Insurance Portability and Accountability Act (HIPAA). Of greatest concern in the HIPAA legislation is Title II. This part of HIPAA details the penalties for violation of HIPAA statutes.
HHS and HIPAA apply to any company that uses or has access to an individual’s private health information. The legislation applies to more than hospitals, nursing homes, and clinics. Any company that does business with a healthcare-related business and has access to private health information is subject to HIPAA legislation.
Here are HIPAA’s Five Important Rules:
The simple answer is, “Yes.”
But the truth is that you have no choice.
To make IT compliance to HIPAA legislation easier for your company and your staff, outsource that side of compliance to an IT specialist.
KalioTek™ isn’t just another IT consulting company. We specialize in biotechnology compliance issues.
To read more about KalioTek™’s biotech compliance service, take a look at some of the outstanding articles on this topic HERE.