To Understand rights about your own healthcare data, you need to understand Real World Data/Real World Evidence

If you are wondering who really owns your medical data and your medical records then you are not the only one. Although the Department of Health and Human Services (HHS) clearly states:

"The Privacy Rule gives you, with few exceptions, the right to inspect, review, and receive a copy of your medical records and billing records that are held by health plans and health care providers covered by the Privacy Rule."

In fact, the HHS provides a Right to Access memo that I think everyone should read (just one page).

There is increasing movement by regulatory bodies such as the FDA to promote #RealWorldData and #RealWorldEvidence. Here is what the FDA is saying:

"Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.

• FDA uses RWD and RWE to monitor postmarket safety and adverse events and to make regulatory decisions.
• The health care community is using these data to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.
• Medical product developers are using RWD and RWE to support clinical trial designs (e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment approaches.

The 21st Century Cures Act, passed in 2016, places additional focus on the use of these types of data to support regulatory decision making, including approval of new indications for approved drugs. Congress defined RWE as data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. FDA has expanded on this definition as discussed below.

Why is this happening now?

The use of computers, mobile devices, wearables and other biosensors to gather and store huge amounts of health-related data has been rapidly accelerating. This data holds potential to allow us to better design and conduct clinical trials and studies in the health care setting to answer questions previously though infeasible. In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze these data and apply the results of our analyses to medical product development and approval.

What are RWD and where do they come from?

Real-world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources, for example:

• Electronic health records (EHRs)
• Claims and billing activities
• Product and disease registries
• Patient-generated data including in home-use settings
• Data gathered from other sources that can inform on health status, such as mobile devices

What is RWE?

Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

This Website was designed to capture up-to-date information about the status of FDA activities around the development and use of RWD and RWE."

The importance of RWD and RWE is explained in this video by @Amgen

Here is another informative video by James Hamrick, MD, MPH, @KaiserPermanente and @FlatironHealth, discussing the importance of real-world data and how it augments traditional clinical trial data.

Are you allowed to license your own data?

What does the FDA authorize to patients who participate in a clinical trial? Here is what the FDA says:

"Paying research subjects in exchange for their participation is a common and, in general, acceptable practice. Payment to research subjects for participation in studies is not considered a benefit that would be part of the weighing of benefits or risks; it is a recruitment incentive. FDA recognizes that payment for participation may raise difficult questions that should be addressed by the IRB. For example, how much money should research subjects receive, and for what should subjects receive payment, such as their time, inconvenience, discomfort, or some other consideration. In contrast to payment for participation, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence. Other than reimbursement for reasonable travel and lodging expenses, IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent. Payment for participation in research should be just and fair. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence [21 CFR 50.20]. "

Here is the full article from the FDA:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects

Why is Real World Data more important today?

Pharmaceutical companies are required to perform randomized clinical trials (RCT) to get drug approved by the FDA, but that data lacks the longitudinal data of the patient. With an abundance of data now available, it is truly a game changer that can provide better understanding of a patient from RWD. Here is what would be considered RWD:

Credits: https://www.researchgate.net/publication/325184395_Innovation_at_the_Intersection_of_Clinical_Trials_and_Real-World_Data_Science_to_Advance_Patient_Care_Innovation_at_the_Intersection_of_Clinical_Trials

What will change with RWD/RWE?

• Potentially this will be a game changer where faster and more efficient drug approval would take place
• If data from various disparate sources could be combined, then valuable data sources could be generated and mined for better outcomes and predictions
• Today academic research centers are predominantly disjointed and a huge need for integration is needed
• A reliable solution which is able to provide security, governance and compliance platform for these data sources would be a starting point

At the @Ventech Solutions Innovation summit a number of pioneers in the field like Dr. Shuvayu Sen (affiliated with Merck), Stella Chang (VP of Veradigm) and Stacey Long (IBM Watson Health) shared their views on the use and adoption of RWD/RWE that was very enlightening. Speakers also included Bill Nottingham VP of Growth from Nottingham Spirk and well known AI image expert Professor Metin Gurcan from Wake Forest University.

We are at the cusp of a healthcare data revolution that will essentially transform the industry in the coming decade. Enormous gains have been made in the computing world with adoption of #artificialintelligence and #machinelearning and we are poised for a better tomorrow for the healthcare industry.