Electronic Health Records or Electronic Medical Records (EHRs/EMRs) are providing information that is impacting risks, risk management and litigation related to pharmaceuticals. I have posted several articles about the legal impact of EHRs at EHRbloggers.com This page provides links with comments about those posts.
My interest in these issues is based on my commitment to reducing costs and improving quality of healthcare. It is supported by my experience with litigation support consulting assignments. I am not an attorney and this material is not offered as legal advice. For legal advice, consult an attorney.
EHR Technology Driving Drug Safety
March 4, 201
Pharmaceutical litigation is where huge lawsuits are common. I predict that this will change and the change will reduce the damage to the bodies and lives of patients, reduce the cost of healthcare, and speed up the process of moving new medications from the laboratory to patients. What will cause that change? …
As a new medication enters the market feedback about its effectiveness and risks will begin to flow very shortly thereafter [in EHRs.] Manufacturers who chose will be able to measure and document effectiveness and will also be able to identify risks. As the patient population using the medication grows, the sample being tracked will also grow. This means that that as risks become significantly large—however significance is determined—the data base will be growing to support both risk assessment and mitigation. Manufacturers, if they chose, will have new opportunities to minimize damage by providing additional information to the medical community and patients and to develop specific responses to specific problems. Timely action will reduce compensatory damages and responsible action will reduce punitive damages. Timely responsible action will reduce damage to the brand in the marketplace.
EHRs Meet Pharma’s Need for Better Risk Management
May 26, 2011
Pharmaceutical product liability lawsuits are notoriously large and represent a major threat to the commercial success of new medications for years after they are introduced. There are new tools available to manage and reduce those risks. … Actual damages provide the basis for lawsuits but punitive damages are often a large part of the final settlement. Early indicators of potential damages offer opportunities to demonstrate concern for patient safety and thereby reduce or avoid punitive damages. … “We didn’t know about the risk,” is no longer a defense, if it ever was one.
EHRs Meet Pharma’s Need for Post-Approval Research
May 23, 2011
Historically, the identification of members of sub-groups and acquisition of additional information has been prohibitively expensive. Rapidly evolving, fully networked, cloud based EMR systems such as Practice Fusion are now being used to collect this data as part of the physician’s normal practice. Data collection, the most costly part of the research process, is now essentially free.
Using data captured by an EHR vendor avoids any real or implied relationship between the doctor who captures it and the pharmaceutical company that uses it. This lends credibility to the outcome by eliminating any appearance of undue influence by the pharmaceutical company on the conduct or outcome of the research.
Personal Health Records Make Care Safer and Cheaper,
April 21, 2011
OTC manufacturers and distributors should find de-identified information about their products and any side-effects or unexpected benefits valuable. … Even a symptom with low frequency can be significant if the harm done to a few individuals is substantial, as it was in that case.
Electronic Health Records and Securities Fraud
April 12, 2011
Can a failure to disclose knowledge about a medication’s side-effects lead to a successful suit for securities fraud? In March 2011 the Supreme Court ruled that it can. … The availability of information from electronic health records with large, near-real-time databases like Practice Fusion’s expands the “total mix of information… available.”
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