As we have duly noted in prior select posts, many individuals and enterprises operating within the health care realm in New York and nationally are routinely under intense public and regulatory scrutiny. And among all those industry participants, there is perhaps no other entity so closely perused as the U.S. Food and Drug Administration, especially…
Doctor-owned medical facilities — chiefly hospitals — are bad for consumers and the public health. No, wait a minute, they’re a positive development that materially promotes a salutary bottom line in a truly broad-based way. Those polar-opposite views are the core bullet points in any debate focusing upon close physician involvement in an ownership capacity…
Health care facilities should be concerned about regulatory compliance matters for the sake of their future business operations. If violations are found, a facility might lose its accreditation and/or right to lawfully operate. Yet according to a recent article, passing an inspection from a private health care accreditor may not necessarily put a facility in…
A doctor who makes it a point to speak to medical student groups and at health-care forums says that she always seeks to underscore for her audience that, “Wow, this is how it happens.” It happens like this for doctors with growing medical practices. Diverse groups of people — termed a “parade of drug, device…
Recent New York-based news relevant to the health care industry bears special significance for one emerging class of participants in that realm, on at least two material fronts. First, a recent money settlement clearly indicates a newly heightened regulatory focus on so-called “digital health companies,” which most consumers might more familiarly know as online health…
Opportunities, yes. And challenges across all dimensions, too, with related management and liability concerns — a reality that is simply a commonplace for American medical actors across all spheres. Any individual in New York or elsewhere who is even remotely connected with the medical industry in any capacity flatly knows the unrelenting bureaucratic and regulatory…
In the realm of federal oversight over marketplace drug approval, do officials from the U.S. Food and Drug Administration act so cautiously that they dangerously slow up the process and materially delay the marketplace entrance of new drugs and medications that many consumers badly need? Or, conversely, do they signal approval in precipitous fashion, so…
One commentator in a recent national media focus on medical actors being targeted in criminal and civil investigations refers to “a new permutation” that is well worth noting in the health care industry. He calls it “the beginning of the next round” for what might be in store for legions of medical industry participants, ranging…
If you are a covered entity in any matter involving the federal Health Insurance Portability and Accountability Act of 1996 (HIPPA), you might derive some comfort from knowing that the legislation does not provide for a private right of legal action against you for any alleged wrongdoing under that law. In other words, HIPPA does…
It really never stops, and that implacable reality becomes firmly cemented for any actor within the medical field the instant that he or she begins training for an ultimate position as a doctor, pharmacist, lab technician, therapist, facility administrator or other role in the industry. “It” is this: the unrelenting scrutiny that is focused on…