INSIDE COMPLIANCE – Page 88 – Loyola University Chicago School of Law

Managing Your Health in 2018: Mobile Medical Applications and FDA Regulations

November 15, 2018Uncategorized

Immediately upon introduction, mobile medical applications became favored by physicians and patients alike because the applications are user friendly and allow the patient to understand their care and participate in more meaningful discussions with their provider about their health. Due to the rapid development of technology and, as a result, a surge of mobile medical applications flooding the market, the Food and Drug Administration has issued three guidances on how they plan to regulate mobile medical applications. In order for mobile medical application manufacturers to remain compliant with the FDA guidances, they must meet the seven categories of requirements that are laid out in Appendix E of FDA’s 2015 guidance and also comply with any further guidance that is released.

Privacy & SecurityRegulation

How the Biggest Nitrogen Polluter of U.S. Waterways Achieves EPA Compliance

November 14, 2018Uncategorized

According to an Environmental Integrity Project report, an Illinois pork-processing plant discharged more nitrogen from animal waste into waterways than any other slaughterhouse in the United States. Yet, the facility has complied with the Clean Water Act since December 2015. Animal-processing operations are not only some of the top polluters, but the federal water pollution standards surrounding these operations are lacking.

agricultureenvironmental regulationEPAnitrogenRegulation

New York Federal Court Rules in Favor of CFTC in its First Ever Anti-Fraud Enforcement Action Involving Bitcoin

November 13, 2018Finance & Banking, Fraud & Abuse

Judge P. Kevin Castel of the U.S. District Court for the Southern District of New York entered an Order for Final Judgment and Consent Order for Final Judgment (“the Orders”) early this month, resolving charges of a Commodity Futures Trading Commission (the “CFTC”) Complaint against a New York Corporation, Gelfman Blueprint Inc. (“GBI”) and its Chief Executive Officer, Nicholas Gelfman. The CFTC’s complaint, filed in January of 2017, marked the first anti-fraud enforcement action involving Bitcoin filed by the Commodity Futures Trading Commission. The Orders found that from approximately January of 2014-January 2016 Defendants Gelfman and GBI, through its officers and agents and employees, operated a Bitcoin Ponzi scheme in which they fraudulently solicited more than $600,000 from at least 80 customers.

Journal of Regulatory Compliance

States Fail At Mental Health

November 12, 2018The Art of Compliance

The Mental Health Parity and Addiction Equity Act (“the Parity Act”) is a federal civil rights and consumer protection law. The Parity Act prohibits most public and private insurance plans from imposing more restrictive standards on mental health (“MH”) and substance use disorder (“SUD”) benefits than they impose on similar medical/surgical benefits. However, ten years since its passage, states have failed to appropriately enforce the Parity Act.

compliancehealthcareHealthcare RegulationsJournal of Regulatory Compliancemental healthMental Health Parity and Addiction ActRegulationsubstance abuse disorder

Proposed Public Charge Intended for Immigrants but will Impose on Health Care

November 9, 2018Uncategorized

Every time we turn on the news, someone is either talking about immigration reform or health care reform. Health care and immigration are two major areas that President Trump promised to address and is attempting to tackle within his first two years in office. Although most would not consider that these two issues would overlap, in today’s American health care system, Americans need immigrants. Immigrants contribute a great deal to our medical research, make up a large percentage of our health care providers, and subsidize health insurance premiums.

ACAAffordabilityEMTALAFederalHealth Carehealth care complianceHealth InsuranceImmigrant SubsidyImmigrantsImmigrationMarketplaceMedicaidMedical ExpendituresMedicare Trust FundpolicyPresident ObamaPresident trumpPreventative CareProposed Public ChargePublic BenefitsPublic Chargepublic healthRegulationSafety Net HospitalUnaffordableUninsured

New SEC Report Cautions Public Companies to Safeguard Assets From Cyber Fraud

November 8, 2018Finance & Banking, Fraud & Abuse

In the age of digitization, data seems less secure than ever. Public companies constantly attempt to safeguard both personal and financial data, yet their efforts fail due to new outbreaks of malicious encryption viruses and persistent email phishing attempts. Data breaches and cyber fraud carry severe financial implications for public companies who fall victim to these types of attacks. But a new Securities and Exchange Commission (SEC) report says that public companies that are easy targets of cyber scams could also be in violation of federal securities laws and accounting regulations that call for firms to safeguard their assets. Although the SEC has issued its warning to public companies about the compliance and financial risks posed by cyber fraud, many companies are still struggling to implement effective protections against newly-evolved forms of cyber-attacks.

asset protectioncyber frauddata securityfraudPrivacy & SecuritySECsecurities exchange actsocial engineering fraud

As Direct-to-Consumer Genetic Analysis Becomes More Popular, Five Privacy Considerations Arise

November 8, 2018Uncategorized

Direct-to-consumer genetic testing kits have exploded in popularity over the last decade. Ancestry.com and 23andMe proudly state they have had ten million and five million customers, respectively, using their DNA testing services. One study projects that improvements in technology and popularity will cause DNA testing to increase tenfold by 2021. Many experts in the field of genetics and bioethics have expressed concern regarding the ability of regulators and privacy infrastructure to keep pace with the expansion of these types of genetic services. We may not be at a point where we understand the full implications of having such large banks of genetic information, but here are five reasons to be concerned.

data privacyGeneticsPrivacy & Security

California to Corporations: No More Male-Only Boards

November 8, 2018Uncategorized

California Governor Jerry Brown signed a historic bill on September 30 that mandates every publicly held corporation whose principal offices are located in California to have a representative number of women on its board of directors. In a letter announcing Senate Bill 826, Governor Brown admits that there are serious legal concerns to the bill and that its potential flaws could “prove fatal to its ultimate implementation” but that it is time to force action regarding the lack of gender diversity on company boards.

companiesRegulation

On Methane Leaks, Obama to Trump Administration Rules Illustrate Fundamental Priority Shift

November 7, 2018Uncategorized

The Trump administration recently delivered a one-two punch to late Obama administration environmental regulations designed to curb the release of methane gas into the atmosphere while simultaneously encouraging its capture for sale. Two Obama era regulations were modified. The first, from the Department of the Interior, was effectively abrogated, while the other stemming from the Environmental Protection Agency (“EPA)” is expected to retain only a fraction of its original force. Environmental groups have already responded to the repeal of the department of interior regulation with a lawsuit in federal court. Methane gas pollution became a greater concern in recent years as the production and use of natural gas as an energy source continues to increase. Proponents of earlier regulations point to methane’s potent contribution to the greenhouse effect, while critics argued the regulations were unnecessary given the natural gas industry’s own efforts and incentives to reduce leaks and capture as much usable gas as possible.

Administrative Procedure ActBureau of Land ManagementcaliforniaColoradoDepartment of the InteriorEnergyEnvironmental Protection Agencyenvironmental regulationfossil fuelsNew Mexicostate regulationTrump AdministrationWyoming

Opportunity Zone Program: Opportunity for Investors or Opportunity for Communities?

November 7, 2018Uncategorized

With the implementation of the Tax Cuts and Jobs Act that was passed in 2017, there have been several changes to the tax system. The Opportunity Zone program was a small piece of the tax reform that has recently gained more publicity. The Opportunity Zone program provides tax benefits to real-estate investors. The Trump Administration recently released definitions and rules in a package of proposed regulations.

economic developmentinvestmentOpportunity Zonesreal estateRegulationtaxTax Cuts and Jobs ActTrump Administration