HIPAA and electronic lab notebook sciNote

HIPAA Compliance and Electronic Lab Notebooks

In this article we will give you an overview on what HIPAA is and how electronic lab notebooks can contribute to the institution’s HIPAA compliance.

HIPAA in general is an incredibly broad subject of great importance to institutions, organizations and companies operating in the healthcare sector. Our aim is to provide an overview for you to better understand it. There are reliable sources available online, such as U.S. Department of Health & Human Services – HIPAA for Professionals that offer detailed help and guidelines on how to address this when setting up processes within your institution.

 

HIPAA – It is not about ticking the boxes

 

In short, Health Insurance Portability and Accountability Act (HIPAA) governs how personal health information (PHI) should be handled by healthcare providers and businesses they collaborate with.

HIPAA covers different aspects of handling PHI such as creating, storing, transferring and sharing the data. It provides guidelines on how to meet privacy and security requirements. Basically, it comes down to whether the system you as an institution established can guarantee that you are using the best technology and practice to protect the PHI of your patients in all aspects. HIPAA is not just a checklist of rules to find and apply. We could say that it actually provides guidelines that cover all aspects of work, from data encryption to training of employees, to minimize risks of security breaches that could compromise patients and the use of their PHI. While it does put an emphasis on the importance of disclosing only minimum necessary information and does define the principles in depth, it still gives the organizations and institutions some room to interpret it and establish their systems in a way that fits their way of work. HIPAA compliance is more like joining a movement you believe in and would like to build your name upon, then ticking the boxes on a checklist.

 

Is HIPPA something you should comply with?

 

As defined by U.S. Department of Health & Human Services, HIPAA applies to healthcare providers e.g. doctors, clinics, pharmacies; health insurance companies, government programs that pay for health care etc.

“The HIPAA Rules apply to covered entities and business associates. Individuals, organizations, and agencies that meet the definition of a covered entity under HIPAA must comply with the Rules’ requirements to protect the privacy and security of health information and must provide individuals with certain rights with respect to their health information. If a covered entity engages a business associate to help it carry out its health care activities and functions, the covered entity must have a written business associate contract or other arrangement (BAA) with the business associate that establishes specifically what the business associate has been engaged to do and requires the business associate to comply with the Rules’ requirements to protect the privacy and security of protected health information. In addition to these contractual obligations, business associates are directly liable for compliance with certain provisions of the HIPAA Rules.” More information

This mainly applies to electronic transmission of information and transactions. Organizations that operate only on paper technically do not have to meet certain regulations. But we do live in the digital age which means that data is going digital. The purpose of HIPAA spreads wider than the question of electronic vs paper and emphasizes the point that the way patients’ data is handled directly affects the way the institution is perceived and the level of trust patients can express towards it. Assessing the risks and making sure that the safety measures are up to date should be an ongoing process, a crucial part of everyday operations within above described covered entities and their business associates.

 

Can an electronic lab notebook i.e. software be HIPAA compliant?

 

No. Electronic lab notebook as a software would be just a small piece of the HIPAA compliance puzzle. You are the one who is putting the pieces together to build the name of your institution and earn the trust from your patients. So your institution can be HIPAA compliant i.e. guarantee safety of PHI and work in accordance with HIPAA.  Which takes us to the next question…

 

How can an electronic lab notebook contribute to an organization’s HIPAA compliance?

 

First, let’s see how an electronic lab notebook (ELN) can fit into the healthcare sector.

Managing patients’ data and medical research data in a comprehensive way is crucial to achieve traceability, efficiency and reproducibility. That is where electronic lab notebooks could help. When it comes to HIPAA compliance, it is impossible to just start using one software and solve the problem. The way to go here is first to address all aspects of PHI security and privacy that an ELN would need to cover within your organization and discuss the options with the team behind the ELN to see how well the ELN’s functionalities fit in.

 

Most important features that an ELN should provide are:

  • Detailed and automated audit trails i.e. activity logs of all users which means that all user’s actions are automatically recorded with date and time when each action was performed
  • Strictly defined roles and permissions of each user within the software that determine who has the authority to see which information and process it further
  • Accessibility of data which means that healthcare professionals authorized to access certain data at certain times need to be able to do so. Here, the compatibility of the ELN with different electronic devices used in the hospital for example can be an important advantage, but also additional security and privacy precautions need to be addressed accordingly
  • Powerful data encryption (check out the HITECH Act for more information on the privacy and security concerns associated with the electronic transmission of health information)
  • Data safety and regular backups to prevent valuable data loss

 

sciNote Premium ELN can provide the above mentioned features.

Since patients’ data is mostly being managed by electronic health record (EHR) and electronic medical record (EMR) software solutions, it is also important that ELNs that would cover the medical research part are able to communicate with these systems. For example, sciNote is offering different levels of customization to its premium customers, including connection of different software systems via APIs.

All in all, HIPAA is giving institutions and organizations the room to implement it in all aspects of their work, in the way that best fits their processes. We, the software providers, are here to make the process as effortless as possible for them.

If you need a solution that would help you meet 21 CFR Part 11 compliance such as electronic signatures, GLP, PCL, ISO 27001 or  HIPAA compliance requirementssciNote Premium would be the option for you.

 

By Tea Pavlek, MSc

 

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sciNote Premium ELN adapts to your needs, meets regulatory requirements and guarantees highest security standards.

 

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