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FDA's regulation of doctor-assisting software criticized

Much criticism of the U.S. Food and Drug Administration from health care analysts and commentators spotlights alleged overregulation of the medical realm and its adverse effects on both business growth and innovation.

That has once again proven to be true in the response of one industry group to recent FDA-authored draft guidance concerning software that assists physicians treating patients.

What is the health industry's biggest concern in 2018?

Health industry actors in New York and nationally face a number of stressing concerns as they go about their important work each day.

And their thoughts are understandably focused squarely on patients while they perform their duties. "Patient safety is on everyone's mind," duly notes a principal with the ECRI Institute, a national nonprofit group that seeks to closely wed scientific research with improved medical outcomes.

Is FDA hiding behind guidance docs to circumvent formal rulemaking?

The process applicable to formal rulemaking engaged in by federal agencies is lengthy and laborious. A recent Bloomberg article discussing how ideas turn into final administrative rules describes it as "cumbersome."

No one likely knows that better than principal employees of the U.S. Food and Drug Administration. The FDA is an agency that is routinely involved with reams of rule-linked documentation that, in instances of final rule implementation, intimately affects scores of thousands of actors within the health care realm.

Regulatory processes ongoing, shifting in health care industry

Given the bottom line linked with human lives and patient safety, it is hardly surprising that the health care realm is one of the most tightly regulated industries in the world.

In the United States, of course, it is the U.S. Food and Drug Administration that plays an especially close and exacting rule in ensuring public health through oversight of drugs, new medical applications, evolving standards relevant to care delivery and so forth.

Health care fraud penalties: wide-ranging and significant

Conscientious health care providers across New York -- doctors, nurses, pharmacists, lab technicians and others -- routinely think about care quality and how to best ensure that their patients are receiving it.

While doing so, though, they are also focused on an additional matter these days that has nothing to do with patient outcomes and that has cast a dark cloud over the entire medical industry.

AARP facing barrage of legal claims in class-action lawsuit

If there is one organization viewed most widely as a friend to baby boomers and America's senior population generally, it is perhaps AARP.

That entity -- the American Association of Retired Persons -- is a nonprofit and self-described nonpartisan group that advocates for the country's senior demographic on relevant issues. AARP additionally provides an array of services ranging from various types of insurance products to discounted prices on lodging and entertainment.

New legislation seeks to tighten regulatory controls over VA

Would-be controls sought to be applied to the U.S. Department of Veterans Affairs underscore the growing degree of regulatory scrutiny being faced by medical actors across the country.

As we have noted in some past blog posts, that scrutiny is always intense, with the medical realm being perhaps the most closely overseen industry in the world.

Implications for sure if Amazon enters pharmacy market in big way

Health care "is complicated," stresses a recent New York Times article.

And, notes that piece, a potential new industry player might soon be coming to grips with just how utterly complex the hoops and hurdles relevant to that huge chunk of the economy can be.

Many states continue to expand Medicaid benefits

A recent study has shown that several states have expanded or enhanced their Medicaid benefits this year, with several planning to do so next year.

The increased benefits were primarily for mental health treatment and substance abuse. Some of the other treatments that saw expanded benefits include telemedicine, dental care, oral contraceptives, and cancer screenings.

What is the New York Office of Professional Medical Conduct?

There is a strong reason why a New York doctor or physician's assistant might want to turn immediately for help to a proven doctors' rights law firm following receipt of an adverse communication -- indeed, virtually any communication -- from the New York Office of Professional Medical Conduct (OPMC).

In fact, there are lots of reasons for picking up the phone.

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