As the number of health data breaches increases, so does the number of domains covered by the Health Insurance Portability and Accountability Act (HIPAA). Biotech is no exception. Given that HIPAA penalties can cost a company millions of dollars, non-compliance can put the very existence of your biotech venture at risk. 

hipaa compliant document management

We understand that the necessity of abiding by HIPAA regulations can be a significant hurdle to the successful outcome of a biotech project. So, in this article, we’ll go through the main concepts of HIPAA and explore ways to secure sensitive patient data with a HIPAA-compliant file sharing solution.

What is HIPAA compliance?

The Health Insurance Portability and Accountability Act (HIPAA) is a set of regulations that revolve around protected health information (PHI), which is any health data that identifies a person. HIPAA specifies how you must collect, store, use, and share PHI. 

Everyone who has access to PHI must comply with HIPAA regulations. Two entities are responsible for protecting PHI: covered entities with direct contact with patients or their information and business associates that provide services to covered entities. For example, a hospital is a covered entity, while an IT development vendor that provides software to this hospital is a business associate.

Main aspects of HIPAA

The main purpose of HIPAA is to protect the privacy of a patient. This goal is achieved primarily through: 

  • The Privacy Rule 
  • The Security Rule 
  • The Breach Notification Rule

The Privacy Rule 

Simply put, the HIPAA Privacy Rule protects the privacy of a patient. First and foremost, it specifies who can access PHI, how, and in what cases. It also regulates how covered entities can use sensitive patient data, as well as when and in what manner they can disclose it. 

Under this rule, an individual patient has the right to control their PHI. For example, as a biotech company, you can’t use PHI for medical trials without the patient’s express consent. 

The Security Rule

As a part of the previous rule, the Security Rule concerns electronic protected health data (ePHI). Interestingly, once the ePHI is printed out, it’s no longer protected by the Security Rule.

While the Privacy Rule is focused on an individual’s rights and how to treat PHI to keep it private, the Security Rule outlines a clear set of procedures you must follow to protect PHI. Notably, these safeguards are scalable, meaning that you can’t apply the same list of HIPAA-compliant storage requirements to a local hospital and an international biotech enterprise. 

The Breach Notification Rule

Under the HIPAA Breach Notification Rule, the covered entities must notify affected individuals, regulators, and sometimes the media if PHI was used or disclosed without permission. Most notifications should be made within 60 days of discovering the breach. If business associates discover the violation, they should inform the covered entity within 60 days. 

How a VDR can help keep you HIPAA-compliant

It might seem that HIPAA doesn’t apply to biotech, and that’s largely so. Still, there are exceptions. For example, you can’t avoid collecting and sharing PHI in most clinical trials or M&A transactions. But how can you keep this information safe when most data repositories are non-compliant, and building a HIPAA-compliant data transfer solution from the ground up for one project isn’t cost-efficient? 

A virtual data room (VDR) can be a perfect solution for HIPAA-compliant video sharing and document transfer. With the help of safeguards required by HIPAA, a data room will give you the needed level of security at a fraction of the cost. Additionally, with various access settings, you’ll be able to control who sees which documents. 

Is this exactly what you need? Then, look no further. An iDeals VDR provides the security you’re looking for.

Why iDeals?

iDeals offers safe virtual data rooms to industries where data security is critical. As a HIPAA-compliant vendor, it applies all cybersecurity measures outlined in the Security Rule and even goes beyond. For example: 

  • It applies TLS protocol and 256-bit AES keys to encrypt your data both at rest and in transit. 
  • It stores your data on servers secured with multiple firewalls.
  • With real-time data backup, it ensures that your data will remain intact in an emergency.
  • It protects its physical data centers with physical security and key card access.

No VDR provider can guarantee you a 100% HIPAA-compliant file transfer without your participation. Given that most projects involve stakeholders with various PHI rights, it’s your responsibility to control who will access information. So it’s essential to use your virtual data room in a HIPAA-compliant manner. Fortunately, it’s effortless with iDeals. 

It offers eight levels of access rights, including Upload, Download Original, Download PDF, Print, and View. It’s also possible to set these access permissions permanently, so nobody will be able to access PHI after the project has ended. Finally, you can lock or delete sensitive information from a lost or stolen device remotely.
As you can see, with iDeals, you have everything you need for HIPAA-compliant document management. So it isn’t surprising that 95 out of 100 top pharma companies trust their confidential documents to this platform.