Tag:

compliance

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.

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.

Following Classification of Cryptocurrencies as Commodities, Regulators Shift Focus

On March 6th, 2018 the. District Court for the Eastern District of New York upheld the classification of cryptocurrencies, such as Bitcoin and Litecoin, as commodities. The ruling subjects the cryptocurrencies to the regulation of the U.S. Commodity Futures Trading Commission (CFTC).

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.

Trump Tower Sued for Non-Compliance with Clean Water Act

Trump Tower is one of many buildings along the Chicago River that uses river water for its cooling systems. Trump Tower is the second largest intake system from the river. Illinois Attorney General, Madigan, filed a lawsuit against the property to ensure that such a large quantity user is not allowed to continue to violate the law. As the value of riverfront property rise, and development continues, enforcement of these types of permits is likely to increase.

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?

The Balancing Act: Exclusive Ownership Rights and Digital Content Sharing

The Internet has given millions of people the capability to share information with each other with just the click of a button. People have grown accustomed to learning about current events, researching, and gathering information all through digital news sources. Unfortunately, the ease of the Internet has also created complications with regulating how users share that information. As technology rapidly advances, the legal limitations concerning intellectual property rights have become blurred, resulting in different interpretations of the Copyright Act of 1976. This has complicated user compliance and created difficult questions for the courts to answer based largely on law that was created before many of the capabilities of the Internet existed. There is a need for consistency and balance in this area of the law so that copyright owners are afforded adequate protection and the Internet can continue to serve as an information gathering, content sharing platform without fostering infringement.

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.  

Building a Compliance Framework from the Ground Up

Large companies generally have well established programs and systems in place to remain compliant with ever-changing regulations within their industry. But at a time when the percentage of job seekers starting their own businesses is at a recent high, young firms and start-ups are at a disadvantage when it comes to compliance, having to build a system from the ground up. In order to have an effective compliance program, an organization must “exercise due diligence to prevent and detect criminal conduct” and must establish and maintain an organizational culture that “encourages ethical conduct and a commitment to compliance with the law.” Thus, management not only has to focus on structure, but also culture in building their compliance systems.