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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.

And, as we have noted in many prior blog posts, industry players -- ranging widely from hospital administrators, physicians and nurses to pharmacists, drug manufacturers and medical device makers -- are constantly on the receiving end of changing regulatory rules and procedures.

This year has hardly spelled an exception to the typically proliferating layers of regulatory and compliance issues that industry participants must adapt to and successfully assimilate.

In fact, 2017 has reportedly been a year of great change within the FDA and for health industry actors that must closely heed its dictates. As one national health publication reports, the agency strove mightily throughout the year "to revise its regulatory processes for the shifting healthcare landscape.."

That means many things, including these developments that affect legions of health care participants and providers:

  • Growing regulatory stress on a pre-certification initiative that places greater reliance on companies' self-driven testing and assessment relevant to the use of mobile digital health devices and online apps
  • Streamlined approval process for direct-to-consumer genetic testing kits that evaluate health risks
  • Identification of more medical devices that can be vetted by makers/providers themselves without advance FDA oversight
  • Expedited approval of new technologies that promise substantial improvements over existing processes

Will 2018 bring more of the same?

It likely will, given the steady march of new and cutting-edge technology in the medical realm. We will keep readers timely advised of material developments.

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