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5 Misconceptions of EHRs in Clinical Trials

The pressures of HIPAA are vast, but they're here to help

There is no debate that we are living in one of the most technologically advanced periods in history. The introduction of tablets, smart phones and other web enabled devices has drastically changed our everyday lives. But have these rapid advances in technology affected the clinical trials market? Absolutely. Unfortunately some professionals continue to shy away from technological improvements because of the many regulations within the pharmaceutical industry. What they need to realize is that the HIPAA rules are in place to help, not hurt, clinical trial progress.

Quality clinical trial data is critical in today's pharmaceutical market. Efficient clinical data management (CDM) is a vital cross-functional vehicle designed to ensure that high-quality data is captured and properly utilized in the trial. An imperative yet challenging goal is turning the mountains of collected data into meaningful information. This information is key to organizations that are working to accelerate patient recruitment, gather and analyze data and enable smoother data query processes. These, among other necessary steps, are central to pioneering study initiatives and new clinical programs to ensure a robust clinical product pipeline.

With these essential factors in mind, there remain multiple misconceptions preventing the entire pharmaceutical industry from taking advantage of innovative technology solutions available today. Solutions that can securely collect, de-identify, transport, store and utilize electronic health records (EHRs).

1. "Storing data electronically on a network just isn't safe enough yet. I feel safer controlling my data in-house whether on local media or even paper."
The US Department of Health and Human Services (HHS) discloses all health record security breaches that affect more than 500 people. In reviewing this information, it is apparent that the majority of data breaches do not involve data stored on a network. In fact, less than 10 percent are related to network breaches. The most common breaches, more than 75 percent, involve physical theft and loss of paper records and portable devices such as a laptop or tablet. It's clear that those who fear storing and sharing data on a secure network are not aware of current HIPAA compliant networks that can eliminate the threats posed by old-fashioned, paper records.

2. "EHR Solutions are just too expensive."
In some cases this can still be true for legacy EHR vendors that charge excessive amounts of money for their solutions. Because of this, as well as educational gaps, paper-based strategies are still commonplace, especially in physicians' facilities. However new EHR technologies, especially web-based network solutions, are emerging fast. These solutions make it easier for practices to join the technology bandwagon, particularly those with a smaller budget. This will help bridge a critical gap between the physicians and those responsible for gathering, analyzing and storing the information. Studies have consistently shown that the upfront costs associated with implementing technology solutions have a surprisingly fast return on investment (ROI). These solutions positively impact every aspect of a clinical trial from increased speed and efficiency, improved quality control at the source to enhanced security and a huge reduction in human errors. With a reasonable price tag and endless opportunities to improve clinical trials, it's surprising not all facilities are taking advantage of modern day technology solutions.

3. "I am concerned because de-identified patient health information (PHI) can easily be re-identified."
The HIPAA Privacy Rule requires PHI to be de-identified or authorized by the patient for release. Entities are to store electronic records on a secure network, train work force members on safeguarding the data and encrypt all data. According to the Office for Civil Rights, the HIPAA guidance for de-identifying PHIs notes two methods for de-identification, the first is a formal review by a qualified expert and the second is a process of removing specific identifiers that could tie the information back to the individual.
Fortunately for the weary professionals nervous to share PHIs for fear of re-identification, there are current solutions on the market that de-identify patient data before it leaves the site, eliminating any fear of identifying the patient after it is sent for use in a clinical trial.

4. "Storing Patient Health Information "in the cloud" is not recommended."
While companies looking to utilize a cloud data storage provider must carefully research their options, there is nothing to fear about the cloud. A reputable provider can provide an extremely secure HIPAA compliant repository for PHI.
As with any technology, there is a certain degree of risk which can be mitigated and controlled via an organization's risk assessment process. This process should begin by fully assessing a potential vendor before committing to any service or if pursuing an in-house solution, the program should be implemented by an individual well versed in all applicable HIPAA regulations. Cloud solutions are more secure than most people perceive and pose no issues in protecting PHI if implemented correctly.

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5. "Mobile Device Applications cannot be utilized."
There is huge potential for the use of mobile devices in clinical trials but it's still a largely untapped technology. Despite the limited challenges, there are many publications that have vouched for the opportunities and benefits from implementing mobile devices. A huge advantage, especially in the study of certain diseases, is real-time patient feedback because most professionals within the pharmaceutical industry have their mobile device on them at all times. Mobile devices allow investigators to monitor patient data in real time and even provide patients with reminders, alerts and access to review their own data. This leads to enhanced communication, reduced office visits and even the possibility of remote clinical trials.

In order to make these technologies a reality, security threats and regulatory concerns must be addressed by utilizing a technology solution that is fully 21 CFR Part 11 compliant. The clinical trial industry can leverage the progress and improvements that other industries have made with mobile security, such as online banking. Advances in technologies will continue to impact the way clinical trials are conducted.

Pharmaceutical professionals must realize that there are solutions on the market today that can dramatically impact and improve the management of a clinical trial. These solutions play a vital role in properly collecting, transporting, utilizing and storing EHRs while adhering to all HIPAA regulations.
As challenging as it may seem to some, it is up to us to learn and adapt to take full advantage of these technologies. The ROI and improved clinical trials will be worth the effort.

James Martin is Senior Manager, Quality Assurance and Regulatory Compliance, AG Mednet.

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It is an interesting point that the majority of data breaches do not involve data stored on a network. Less than 10% are related to network breaches. However, the most common breaches, 75 percent, involves physical theft and loss of paper records and portable devices.
Also, I am learning more about cloud data storage.

Claudette  Singleton April 25, 2014
Wenonah , NJ

I want to know more about the new HIPPA rules which apply to the EHR. I would also like to know how the EHR is going to effect medical transcription.

Gail Lancon,  unemployedApril 02, 2014


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