Your Health Records aka Designated Record Set

When I ask my doctor for my health records, what can I expect to receive? In what form (electronic or paper) are these health records kept?  My health records are the systematic documentation of my healthcare history and care over MY life. Asking simply for your health records is too vague and opens up the door to getting less than the law allows you to get. While more than one set of health records are typically kept by healthcare businesses, the health records that are important to patients are called the designated record set (see Federal Regulation 45 CFR 164.501 – Definitions).  Your Protected Health Information (PHI) contained within the designated record set must be available to you for inspection under HIPAA.  You are also guaranteed the right to receive copies of the files in this set of health records.

health record equals designated record set

If you want to look at all of the health records that you are entitled to see, ask to inspect your designated record set.  You are telling the healthcare provider that you know what the law gives you the right to see.  These health records can be used for coordination of care, second opinion consultation (sharing) with other health professionals, to save in your Personal Health Record (PHR), and for increased “engagement” in your healthcare. These health records (stripped of all identifying information) can also be used for public health functions that benefit all Americans.  For example, if a particular treatment was ineffective for me, this data could be used to change how future patients are treated.

The designated record set documentation can take a form that you can physically touch (like paper, photographs, xray images) or in electronic file formats that can be accessed (and saved) using a computer or other electronic device. FAX copies of health records fall in the paper form of health record documentation and are fast becoming an out-dated form of communication. You can still request paper copies of your health records, but electronic copies are much more portable and shareable (interoperable, in government-speak) with other healthcare professionals!  .

Electronic forms of your Protected Health Information (PHI) in the designated record set are usually found in the healthcare business’s Electronic Medical Records (EMRs) and should be accessible from your online Electronic Health Record (EHR). Doctors often refer to your Electronic Health Record, introduced thanks to the HITECH Act of 2009,  the “patient portal”.  In electronic form, these health records consist of a collection of files and are designed for communication and sharing between healthcare providers and between patients and healthcare providers during coordination of care and second opinion consultation.

You should expect to see the following types of records within your designated record set:

  • Clinical records—documents that include history and physical examination reports, vital signs, orders, medical notes (e.g., progress, outpatient clinic), assessments, medical consult reports
  • Source Clinical (“Raw”) Data—includes X-rays, images, fetal strips, videos, pathology slides
  • External Records and Reports—records obtained from other healthcare providers, labs, hospitals, or patients (clinical reports (includes radiology, operative, pathology), and hospital discharge summaries)

Let us look at each of these types of records individually below.

The Designated Record Set

Clinical records

Clinical records are a collection of notes and reports that are generated from patient encounters with healthcare providers and hospitals. They are the healthcare business’s “evidence of patient care” and can be handwritten, typed, or in electronic (digital) format. There are standard ways that these notes and reports are generated (doctors are taught how to write them). Clinical records must be clear, factual, consistent, accurate, legible, timely, dated and signed by the healthcare professional. These notes and reports are often accompanied by supporting source clinical data (see below). Clinical records are an integral part of high quality treatment and care and all healthcare professionals have a responsibility to record accurate information about the care they are providing.

Clinical records include:

  • An initial patient history including history of present condition, presence of chronic (long-lasting and not curable) health conditions (like asthma, diabetes), details of current medications, immunization dates, allergies, past medical history and relevant lifestyle history
  • A record of initial physical examination
  • A written diagnosis (reason seeking healthcare services)
  • Consultation, progress notes, observations
  • Treatments, drug therapy records, and/ or other interventions provided
  • Plans of care shared with patients and decisions made
  • Legal documents (like signed consent forms)
  • Admission and discharge documentation (hospitals)
  • notes of all unexpected events and any actions taken
  • All other notes made by doctors, nurses, and other healthcare professionals (like social workers)

Source Clinical (“Raw”) Data

The health records that are generated by medical equipment (called source clinical data by the healthcare community) is data that healthcare professionals use for diagnosis, screening, and monitoring. Without this “raw” health data, the doctor would be severely limited in his ability to diagnose illness and disease today (think Dr. Quinn Medicine Woman doctoring). A final diagnosis, especially for a condition that is not obvious, often calls for combining and interpreting the results from several source clinical data. Examples of diagnostic medical equipment from which source clinical data is derived, include various medical imaging machines (e.g., ultrasound, MRI, x-ray, and CT scanners), various chemistry analyzers (blood, urine), and monitoring equipment (e.g., electrocardiograph (ECG) and electroencephalograph (EEG))

I call the output from medical equipment “raw” data” because it requires interpretation to have meaning in health care. A mammogram, x-ray, ultrasound, CT scan, or MRI are all source clinical (“raw”) records while a radiologist’s report about what he saw on the “raw” image is not. Original blood test results are “raw” health records, but if the original blood test results are inputted into a separate form, then it is no longer “raw” health records. Pictures (like high-resolution images of the eye) and videos (from cardiac catheterization or micro-surgery) are also “raw” health records. In the figure below, I have included several source clinical (“raw”) data examples that have been saved in electronic (digital) format. (top row: optical micrograph showing cancer cells on a biopsy slide, endoscopic image of polyp in colon, CT scan of clot in heart, EEG output, bottom row: X-ray of fractured arm, mammogram showing tumor, and optical “fundus” photograph of eye showing diabetic eye disease)

source clinical data in designated record set

External Records and Reports

External records and reports come from outside the healthcare business. For example, your general practitioner might want a record of your hospital discharge summaries and various source clinical data generated at  outside facilities (like hospitals). Patients are a big source for external records and reports when second opinions and coordination of care are requested and the personal health information shared. Patient correspondence also falls in this category.

The Bottom Line

The health records that you are entitled to inspect and/or receive a copy (per HIPAA) is the Protected Health Information (PHI) contained within your designated record set .  You must use the highlighted words (and not simply “health records”) to make sure you are getting what you are entitled to access.  Putting your request in writing is always best.

The designated record set contains clinical records; source clinical (“raw”) data from medical diagnostic, monitoring, and screening equipment; and external records and reports. These health records can be in paper or electronic form. Your access to health records is important for coordination of care and second opinions with other health professionals, for inputting into your Personal Health Record (PHR), and for increased “engagement” in your healthcare.

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