Today's News and Commentary

About healthcare IT

Physician Time Spent Using the Electronic Health Record During Outpatient Encounters: A Descriptive Study: “Physicians spent an average of 16 minutes and 14 seconds per encounter using EHRs, with chart review (33%), documentation (24%), and ordering (17%) functions accounting for most of the time. The distribution of time spent by providers using EHRs varies greatly within specialty. The proportion of time spent on various clinically focused functions was similar across specialties.” Clearly there is much more opportunity for streamlining EHR interaction.

Too many providers are failing to meaningfully integrate data analytics: “Healthcare providers are failing to integrate digital data platforms into their IT infrastructure, and analytics into their clinical and operational workflows. This despite widespread availability of the technology – and a definite need for it, given the demands of value-based reimbursement…
84% of the C-suite execs and board members polled said their health systems only used analytics to a  ‘limited or minimal extent to generate commercial or outcome insights,’ according to the survey.”

About pharma

Hospitals are getting into the biopharma sector. Last month I reported that NYU Langone Health opened a 50,000-square-foot biotech incubator space in Manhattan to host startups. The past couple days, two other hospitals have announced their entry in this space. Nationwide Children's Hospital will build a biofactory to produce gene therapy material while “University of Pittsburgh Medical Center's venture capital arm is committing $1billion in investments toward developing new drugs, diagnostics and devices by 2024.”

Drugmakers Test New Ways to Pay for Six-Figure Treatments [Wall Street Journal, requires subscription]: This excellent article provides a useful video explaining all the stakeholders in the pharma transaction chain and some of the creative arrangements manufacturers of very costly drugs have structured with payers- like pay for success and installment payments.

Supreme Court Declines to Consider Medical Diagnostic Patents: “The U.S. Supreme Court stayed out of the debate over what types of medical diagnostic tests can be patented, leaving in legal limbo companies that discover ways to diagnose and treat diseases based on patients’ unique characteristics.
The justices rejected an appeal by Quest Diagnostics’s Athena unit that sought to restore its patent for a test to detect the presence of an autoimmune disease. A lower court had ruled in favor of the nonprofit Mayo Clinic that the test wasn’t eligible for a patent because it merely covered a natural law—the correlation between the presence of an antibody and the disease.” "Laws of nature, natural phenomena, and abstract ideas" cannot be patented under Section 101 of the Patent Act.

FDA and NIH let clinical trial sponsors keep results secret and break the law: “For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.” The article has a graphic of different prominent stakeholders and their reporting (un)timelines. As the FDA is moving to incorporate more real world evidence for drug evaluations, it needs to be stricter about reporting.