HIPAA AND ITS IMPORTANCE IN CLINICAL TRIALS

HIPAA AND ITS IMPORTANCE IN CLINICAL TRIALS

 INTRODUCTION

The privacy of any health information has become an important aspect for all healthcare delivering systems. The healthcare providers should ensure the effective ways to safeguard the security and privacy policies of the patient rights. Any health record should be maintained under strict conditions.

There is a need to enroll the global standard to handle the patient data and also for electronic transfer of the information. And there is a need to establish all the guidelines to protect and control the records both written and oral.

The first and most important consideration of federal legislation on health privacy and security is the HIPPA.

WHAT IS MEANT BY HIPAA?

•  Health
•  Insurance
•  Portability and 
•  Accountability 
•  Act 

WHAT ARE THE MAIN GOALS OF HIPAA?

•  To make easier all the laws in accordance with people and to keep health insurance.
•  In order to protect the confidentiality and privacy of any information which is related to health.
•  It helps healthcare industries to control the administrative expenses.

WHY HIPAA CAME INTO PICTURE?

HIPAA was signed in 1996.

In 2000 many patients who were newly diagnosed with depression had received free samples of anti-depressant medications in their mail. Then they have wondered how the pharmaceutical companies know about their disease.

After many investigations they came to know that the physician, pharmaceutical company and a chain of well-known pharmacy people all are indicated on a breach of confidentiality charges.

This the main reason that the federal government needed to take the measures and create guidelines to protect the privacy policy of patients.

WHAT ARE THE TWO DIFFERENT SECTIONS OF HIPAA?

PORTABILITY:

It helps every individual to carry their own health insurance from one job to another, so that they don’t have a lapse in coverage.

It also restricts all the health plans which require preexisting condition of an individual who switch from one health plan to another.

ADMINISTRATIVE SIMPLIFICATION:

It establishes all the set of standards for receiving, transmitting and to maintain the healthcare information.

It also ensures the security and privacy of individual identifiable information.

WHAT INFORMATION OF THE PATIENT TO BE PROTECTED?

WHO MUST COMPLY WITH HIPAA?

The people who are responsible for implementing HIPAA are mainly:

•  Healthcare providers like physicians, dentals and laboratories
•  Health plans 
•  Health insurance clearing houses like immediate consultancies.
•  Healthcare transactions.

WHO SHOULD NOT COMPLY WITH HIPAA?

•  Government employers
•  Child protective services
•  Central and state police or enforcement agencies
•  Schools.

WHAT DOES HIPPA COMPRISES OF?

•  It consists of a standardized electronic data interchange transactions and codes for all covered entities.
•  It consists of all the standards which are required for securing the data systems.
•  There are many privacy protections options for every individual health information.
•  Standard national identifiers for healthcare.

HOW CAN HEALTHCARE PROVIDER PROTECT THE PATIENT’S PRIVACY?

WHAT IS HIPAA PRIVACY RULE?

•  It makes sure all the policies should be applied in a proper way to ensure the proper protection of the data.
•  It makes all the policies in health care and uses the Protected Health Information for handling any patient related issue.
•  Written or electronic permission from the patient is required to access their medical data

WHAT IS HIPAA SECURITY RULE?

• It implements all the requirements to protect the electronic personnel health information (ePHI) and which is maintained by covered entity.
•  It also provides the documents which are required to ensure the confidentiality, integrity and availability of ePHI.
•  Documentation standard also has three major policies like time limit, availability and update.

WHAT LEGAL EXCEPTIONS WILL A HEALTH CARE PRACTITIONERS CAN BREAK WITHOUT PERMISSION FROM THE PATIENT?

• A wound made by a bullet from the gun. 
• A stab wound when someone has been stabbed with the knife. 
• Injuries which may occur in a crime
• Children/Elderly abuse
• Infectious, transferable or reportable diseases.

ELECTRONIC HEALTH RECORDS AND HIPAA

The utilization of electronic health records in the healthcare industry has been evolving continuously. 

Stage 1: Which was turned out in 2010, formed a steady establishment for medical service providers by empowering the utilization of electronic medical records.

Stage1 concentrated much on which and how patient data can be stored and to maintain electronic records form. Essential required data keeps on including patient medical history, medication (past and current), hypersensitivity data, diagnoses.

Stage 1 additionally tended to circumstances where a patient may have initially been treated at one site yet is then treated at an alternate site. In this situation, all the information about every treatment, including lab work, pictures, diagnosis, must be put away in a protected way in that patient's e-record. This necessity applies to both new and existing patients. 

Stage 2:  Which was turned out in 2012, addresses how suppliers and patients get access, share, store and update electronic medical records.

In this procedure medical experts are challenged to incorporate and maintain a series of guidelines and prerequisites governing patient medical records information reporting and HIPAA (Healthcare 

Insurance Portability and Accountability Act) compliance.

Patients must be allowed access to their electronic medical records inside a 36-hour term from the requested date and time. 

Secure messaging is currently incorporated into the record keeping process. 

The wellbeing conduct of patients must be checked electronically. 

Related pictures should likewise be stored in the patient's e-records document. .

Stricter controls must be executed to ensure patients don't access unauthorized prescription medications through a hand-off framework from specialist to administrator to pharmacist to patient. 

IMPORTANCE OF HIPAA IN CLINICAL TRIALS:

Recruitment:

The Privacy Rule allows a doctor to select her own patients, like for example, sending a letter to patients who are eligible to recruit in a clinical trial, or by talking with the patient and recruiting them during an office visit.

Written HIPAA authorization and informed consent are required to enroll a patient in the actual clinical trial.

Although not a HIPAA requirement, physicians are also  concerned about patients' privacy and  should consider limiting recruitment to calls placed by the physician (or office staff), letters signed by the physician, and brochures in the waiting room instructing interested patients to contact the CRO conducting the study.

How to enroll and conduct of study with HIPAA

The physician should obtain written HIPAA research authorization to select a patient in a clinical trial. The sponsor will give a template consent form, and also the research site, which is a covered entity, must supply the HIPAA authorization. The complete authorization and consent forms are combined together which is allowed, provided that the combined form contains all the aspects required by both the Privacy Rule and federal research regulations.

A HIPAA research authorization should contain all the elements of a valid general HIPAA authorization. The core elements of a valid general authorization are found at 45 C.F.R. The physician should take the sign regarding the research authorization from patients who want to participate in the research. The research authorization should indicate a patient's right to access research information entered in medical or billing records will be suspended until the research end.

How can we do publication or Interpretation of results

HIPAA keeps on applying when the results of clinical trials are published or introduced to a group of people. But when conducting internal activities related to medicine, doctors must get a HIPAA authorization before publishing papers or any information of PHI. An Institutional Review Board may not postpone approval for the distribution or introduction of research.

BY : LEKHASREE KASARLA

MAIL ID: lekhasreekasarla@gmail.com