On April 8, the Food and Drug Administration issued draft guidance titled "Cybersecurity in Medical Devices

Telehealth is not new, but during the pandemic, it has received renewed attention and support because of its ability to expand access to health care.

The American Nurses Association (ANA) recently unveiled its leading federal legislative priorities for Congress covering safe staffing, nursing workforce development, home health, the opioid epidemic, workplace violence and COVID-19.

On June 21, 2021, the Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) that was designed to protect healthcare workers from exposure to COVID-19 in settings where people with COVID-19 were reasonably expected to be present.

The No Surprise Act (the "Act"), which became effective January 1, 2022, creates federal protections against surprise medical bills.

When it comes to Medicare, billing under the wrong physician's ID can cost doctors and hospitals - literally.

As we look ahead in 2022, it's a good opportunity to re-visit key regulatory challenges from 2021 and what potentially lies ahead in each of these key areas.

Diabetes is the epitome of "an ounce of prevention is worth a pound of cure."

The Alabama State Board of Medical Examiners and the Alabama Licensure Commission have proposed a complete overhaul of the rules affecting medical record management by Alabama physicians (the "Proposed Rule").

On November 8, 2021, the United States Department of Health and Human Services ("HHS") amended its provider self-disclosure protocol (the "SDP") which was originally published in 1998 to establish a process for health care providers to voluntarily identify, disclose and resolve instances of potential fraud involving federal healthcare programs.

In October, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the "Departments") and the Office of Personnel Management jointly released rules that implement the dispute resolution provisions of the No Surprises Act (the "Act").

Physician groups should check their income distribution plans to make sure they comply with new Stark changes that will go into effect January 1, 2022.

Health care providers across the United States continue to face an acute shortage of physicians particularly in Medically Unserved Areas ("MUAs") and Health Professional Shortage Areas ("HPSAs"), which areas are determined by the United Stated Public Health Service and which include certain areas in and around Alabama.

In yet another reversal by the Biden Administration of a Trump-era policy, the Centers for Medicare & Medicaid Services (CMS) recently released a proposed rule reversing the Trump Administration's decision to eliminate the inpatient-only service list (IPO List) over a three-year period.

In July, major healthcare organizations signed a letter of support for the recent reintroduction of a bipartisan bill to support accountable care organizations (ACOs) and other alternative payment models (APMs), while also addressing an unintended consequence of the ACO formulary, known as the 'rural glitch,' that punishes rural hospitals even when they achieve savings.

On June 21, 2021, the Occupational Safety and Health Administration ("OSHA") published an Emergency Temporary Standard ("ETS") that requires healthcare employers to take certain precautions to protect workers from COVID-19.

On May 17, 2021, Alabama Governor Kay Ivey signed into law the Darren Wesley 'Ato' Hall Compassion Act (the "Medical Marijuana Law")

The Trump Era 2017 Tax Cuts and Jobs Act changed the tax code by reducing the income tax brackets of individuals and corporations.

Healthcare enforcement actions take multiple forms.

On December 10, 2020, the Office for Civil Rights (OCR) at the United States Department of Health and Human Services (HHS) announced proposed changes to the regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Like many states, the Alabama legislature passed, and Governor Ivey signed into law, a bill that provides civil liability protections to Alabama businesses and healthcare providers related to COVID-19.

Even before the pandemic, change was in the air.

On January 19, 2021, the Office for Civil Rights ("OCR") at the U.S. Department of Health and Human Services ("HHS") announced that it will exercise its enforcement discretion and will not impose penalties for violations of the HIPAA Rules in connection with the good faith use of online or web-based scheduling applications (collectively, "WBSAs") when used for scheduling individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency.

As if hospitals don't have enough challenges with the fallout from COVID-19, they also need to comply with the new Hospital Price Transparency Rule (See 45 C.F.R. Part 180) which is effective January 1, 2021.

Although HIPAA is probably best known for its privacy and security provisions, it also affords certain essential rights to ensure that individuals have access to their medical records.