How are Research Data and Clinical Data Handled Differently?

As we capture more clinical data electronically and the significance of clinical performance on payment grows, organizations are adding ‘research’ to the list of uses for their clinical data. One common question is: “What is the difference between research data and clinical data and how are they handled differently?”.

clincal research venn

What is clinical data?

For the sake of simplicity, let’s use two slightly different, yet very common definitions of clinical data:

  1. Any data captured and used for the purpose of supporting clinical care. This would included labs, notes, prescriptions, etc., but not billing data which would be considered ‘administrative  data’.
  2. Any information created by a health care provider that relates to the physical condition of an individual, the provision of health care, or payment health care.

Definition1 makes the distinction between clinical data and administrative data (e.g. one is for billing and the other is for care), while definition 2 includes all of the above plus utilization data. Utilization data is what is ordered, what is done, what supplies are consumed, etc. You might also recognize that definition 2 is related to HIPPA, one of the federal policies related to health data.

Whichever definition you use, clinical data takes a variety of forms, from billing codes, to lab results, problem lists,  a patient’s tobacco history, even communication between providers about a patient can be considered part of the clinical record.

What is Research Data?

This one should be simple to define as well. However, like clinical data, may largely depend on the context to which you are describing.  The Office for Human Research Protections says this:

[data collected ] as part of a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration) 45 CFR 46

As you can see, clinical data and research data may sometimes be very different things, or sometimes the same thing. You don’t have to be an academic medical center to handle research data that is also (or used to be) clinical data. Lots of hospitals and individual providers keep registries and participate in research studies with their patients. Cancer in particular, is an area where research is frequently the standard of care. In some setting such as these, clinical trials provide the best care possible for your patients.    Moreover, a growing number of health care delivery organizations are also doing formal studies to evaluate new products, clinical pathways,  or discover new operational efficiencies.  Activities that are frequently considered quality improvement projects may also legally be considered research.

How They Are Handled Differently

For starters, clinical and research data may be collected in different ways that reflect their different purposes. Research data is collected as accurately as possible with an emphasis on reproducibility, sometimes at the expense of cost or efficiency.  For example, a specific laboratory test (sometimes from a specific lab) may be required for a research study. Whereas if it was not specified for research the provider might have typically used a different test or needed no test at all. Definitions may also be different between clinical data and research data.  A primary care provider may list ‘depression’ in the problem list for a patient based on their assessment, but this definition may not pass muster to a psychiatric researcher who may require documentation of 5 or more depressive symptoms over a two week period.

Clinical data and research data might also be stored and handled differently according to the policy or regulation that applies.  Both types of data have privacy regulations that protect the patient (or subject) from privacy and confidentiality breeches. At the heart of these policies is the definition of personally identifiable or protected health information  and what you can do with it.

For HIPAA, it is ” appropriate administrative, technical, and physical safeguards to protect the privacy of medical records and other protected health information (PHI) for whatever period such information is maintained.” See 45 CFR 164.530(c). Research that is covered by the FDA (such as a clinical trial),  covered by the institution’s review board, or funded by government or nonprofit organizations have additional privacy considerations.

Many organizations operate under the assumption that HIPAA requires data retention for 6-7 years, however HHS states here that HIPPA doesn’t specify how long you have to keep clinical data, CMS and state laws do, however have retention rules.  See here for the list of states and their medical record retention laws:

Research data also has retention rules that are usually specified by the funding organization.  The rules vary depending on the type of research as well as the type of data.  For example,  HHS regulations requires that IRB records be retained for at least three [3] years after the conclusion of research.

Keep in mind,  for data to be covered under HIPAA, the health information has to be created by a health plan, health care provider, clearinghouse, or business associate per Health and Human Services definition of these.  For research data to be covered, it has to be subject of other rules.

 

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Dr. Jonathan P. DeShazo is an expert on health information technology, clinical data, and consumer informatics. He is currently an Assistant Professor in the Department of Health Adminstration and serves as Scientific Director of the Biomedical Informatics Core at Virginia Commonwealth University.

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