Tag:

Regulation

Electronic Health Record Compliance Measures Benefit Patient Centered Care

In a time when data breaches occur fairly frequently, whether it’s credit card information being stolen from department stores or a credit reporting bureau breach affecting hundreds of millions of customers, keeping personal information private seems to get harder every day. That fact may give patients pause when they are asked to sign up for an electronic health record account. A 2017 survey listed electronic health record management as one of patients top concerns. Changes in recent years have led to changes in compliance measures that make electronic health records security an added benefit to patients and ensure the continued increase of their adoption.

FDA Declares War on Flavored E-Cigarette

In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.

DeVos’ Deregulation Attempt Fails as Judge Upholds Borrower Defense Rules

A new set of student loan forgiveness regulations introduced earlier this year aimed to hack away at “borrower-defense” protections which shielded students from predatory loan practices by for-profit universities. Under Education Secretary Betsy DeVos, the Department of Education crafted new, more restrictive borrower-defense regulations after blocking an Obama Administration regulation from going into effect last year. U.S. District Court Judge Randolph Moss sided with consumer rights activists who argued against the Secretary of Education, alleging the Department of Education violated federal law and procedure by repealing the Borrower Defense to Repayment rule. The Trump Administration requested another opportunity to delay the regulations from taking effect, but Judge Moss has not yet ruled on their request. 

A Way Around HHS 340B Program Delays

Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute. 

GDPR, Data, & Blockchain: The New Wonders of the Digital World

In a world where our reliance on technology and the cloud is increasing exponentially, data security’s growth has stagnated. The European Union (EU) passed the General Data Protection Regulation (GDPR) in hopes of ensuring that consumer data is protected and not harbored by businesses. The effects of the GDPR, however, have passed the borders of the European Union. In a world where our actions extend internationally with just the click of a button, the GDPR’s impact circles the globe as well. The GDPR has pushed for a shift in data privacy and regulation for companies within and outside of the EU as it holds to protect European citizens, no matter where they are in the world. This international reach has not only created forces to drive U.S. companies to comply, but states within the U.S. are now creating GDPR-inspired laws to protect their own citizens. The GDPR has started a trend that will soon become the norm and finally push compliance to keep up with the exponential growth of technology.

Can Congress Regulate Big Pharma?

Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.

The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For

Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?

Popularity Contest: The Importance of Reputation in Modern Compliance

Modern business thinking has come to accept that reputation is as important as financials. As investors look for companies that demonstrate this understanding, compliance professionals are in a unique position to make their companies more appealing.

Trump Administration Deregulates Housing

As President Donald Trump continues to deliver on his promise to deregulate, the Department of Housing and Urban Development (HUD) has been instrumental in reversing Obama-era regulations.  President Trump, who made his fortune in real estate development, has a checkered past when it comes to fair housing and discrimination.  Now his administration is working to cut funding to HUD and unwind many fair housing and discrimination rules.  Administration proponents say this is a necessary step to fix a broken and corrupt bureaucracy, while many advocates have expressed concern over the government scaling back enforcement of fair housing laws.  Any reform effort should seek to balance concerns about bureaucracy with the vital missions of fair discrimination-free housing, inclusive communities, and civil rights.  

Deregulation of Uranium Mining or: How I Learned to Stop Regulating and Love the Bomb

Compliance professionals all over the country are paying close attention to the Trump administration’s deregulatory campaign. While deregulation in finance has received the most media attention, the uranium mining industry has been a quiet beneficiary of the President’s new regulatory scheme.