The new regulations provide protection for the privacy of certain individually identifiable health data, referred to as protected health information PHI. Although it is not a defined term, DHHS interpreted the phrase "authorized by law" to mean that a legal basis exists for the activity.
For example, if a cloud vendor hosts encrypted PHI for an ambulatory clinic, privacy could still be a liability if the vendor is not part of a business associate agreement.
Judicial and administrative proceedings. Some public health activities that are initially public health practice may subsequently evolve into a research activity e.
According to the US Department of Health and Human Services, protected health information PHI is individually identifiable information see below for definition that is: DHHS recognized the importance of sharing PHI to accomplish essential public health objectives and to meet certain other societal needs e.
Research Versus Practice The definition of research is the same for the Privacy Rule and the Common Rule 10 systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Thus, the Privacy Rule provides for the continued functioning of the U. The purpose of de-identification and anonymization is to use health care data in larger increments, for research purposes. Examples of such activities include those directed at the reporting of disease or injury, reporting adverse events, reporting births and deaths, and investigating the occurrence and cause of injury and disease 1.
Covered entities may report adverse events related to FDA-regulated products or activities to public agencies and private entities that are subject to FDA jurisdiction [45 CFR To understand the possible impact of the Privacy Rule on their work, researchers will need to understand what individually identifiable health information is and is not protected under the Rule.
When that is the case, a limited data set may be useful. However, the lines between PHR and PHI will blur in the future as more digital medical records are accessed and shared by patients. For example, the Privacy Rule does not cover employers, certain insurers e.
It would not apply, however, if the disclosure were required by law, authorized by the individual, or for treatment purposes.
A provider of health-care services and any other person or organization that furnishes, bills, or is paid for health care in the normal course of business. In certain instances, working with de-identified data may have limited value to clinical research and other activities. Balancing the protection of individual health information with the need to protect public health, the Privacy Rule expressly permits disclosures without individual authorization to public health authorities authorized by law to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability, including but not limited to public health surveillance, investigation, and intervention.
There are, however, instances when individually identifiable health information held by a covered entity is not protected by the Privacy Rule.
Individuals have the right to request a restriction on certain uses or disclosures of their PHI; however, the covered entity is not obligated to agree to such a request. The Privacy Rule permits covered entities to disclose PHI, without authorization, to public health authorities or other entities who are legally authorized to receive such reports for the purpose of preventing or controlling disease, injury, or disability.
Organizations cannot sell PHI unless it is for public health activities, research, treatment, services rendered, or the merger or acquisition of a HIPAA-covered entity. The Privacy Rule continues to allow for the existing practice of sharing PHI with public health authorities who are authorized by law to collect or receive such information to aid them in their mission of protecting the health of the public.
Impact on Public Health Public health practice and research, including such traditional public health activities as program operations, public health surveillance, program evaluation, terrorism preparedness, outbreak investigations, direct health services, and public health research, use PHI to identify, monitor, and respond to disease, death, and disability among populations.
More complete definitions of these, and other terms, are located elsewhere in this report Appendix A. The underlying point of MyHealthEData is to encourage healthcare organizations to pursue interoperability of health data as a way of allowing patients more access to their records.A covered entity may use and disclose protected health information for its own treatment, payment, and health care operations activities.
19 A covered entity also may disclose protected health information for the treatment activities of any health care provider, the payment activities of another covered entity and of any health care.
Electronic protected health information (ePHI) is any protected health information (PHI) that is created, stored, transmitted, or received electronically.
Electronic protected health information includes any medium used to. The Health Insurance Portability and Accountability Act of (HIPAA) privacy rule uses Protected Health Information (PHI) to define the type of patient information that's protected by law.
PHI is an important factor for HIPAA compliance. PHI stands for Protected Health Information and is any information in a medical record that can be used to identify an individual, and that was created, used, or disclosed in the course of providing a health care service, such as a diagnosis or treatment.
Protected health information (PHI), also referred to as personal health information, generally refers to demographic information, medical histories, test and laboratory results, mental health conditions, insurance information, and other data that a healthcare professional collects to identify an individual and determine appropriate care.
This information is called protected health information (PHI), which is generally individually identifiable health information that is transmitted by, or maintained in, electronic media or any other form or medium.Download