Tag:Regulation
Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988
The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies. The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.
HIPAA May Not Be Enough to Protect Our Health Information
On March 1, 2019, the College of Healthcare Information Management Executives (“CHIME”) sent a six-page letter to Congress which discussed how technology has impacted health care costs. CHIME believes that too much money is being allocated towards making sure that health care organizations are complying with the Office of Civil Rights (“OCR”) and the Department of Health and Human Services (“HHS”) requirements, while not enough resources are being given towards actually protecting against cybersecurity attacks. The letter contains multiple suggestions in which patient data could be better protected, such as incentivizing health care organizations to implement more cybersecurity safety measures. However, many of CHIME’s proposals would require Congress to amend multiple provisions in acts, such as the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”).
The Ugly Side of Beauty: How Under-Regulation of Cosmetics Harmed Consumers for Decades
It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.
Sunscreen Regulations: Providing Protection for Consumers and Difficulties for Manufacturers
In 2014, Congress passed the Sunscreen Innovation Act in the hopes of encouraging innovation for new sunscreen ingredients. Recently, the United States Food and Drug Administration (FDA) proposed new regulations regarding over-the-counter sunscreens to keep up with recent scientific and safety information. This proposal will be available for ninety days from its announcement on February 21, 2019, and addresses safety concerns of common sunscreen ingredients. Further, the proposal addresses the labeling of sunscreen, trying to make it easier for consumers to identify the product information. While this proposal seeks to alleviate safety concerns, the regulation could potentially make it more difficult for new ingredients to be approved.
Tragic Dam Collapse Leads to Calls for Real Change
At 12:28pm on January 25, 2019, a thirty-story high tailings dam operated by Brazilian mining giant Vale suffered a catastrophic failure, unleashing an estimated 12 million cubic meters of mining waste on the town of Brumadinho, Brazil. The collapse killed 177 people, and 133 others are missing and presumed dead. Perhaps the most devastating part of this tragedy is the simple fact that it should have never happened.
Health and Human Services Promulgates New Abortion “Gag” Rule; Opponents Prepare for Legal Challenges
On February 22, 2019, the Department of Health and Human Services submitted a final rule to the Federal Register, substantially altering existing guidelines for family planning programs’ reception of federal funds under Title X of the Public Health Service Act (PHS Act). Among other things, the new regulations prohibit qualifying programs from referring patients to abortion providers. Public statements from organizations such as Planned Parenthood suggest lawsuits for injunctive relief are imminent.
Facebook’s Watching… For Now
Ever since the Facebook and Cambridge Analytica scandal, concerns surrounding data privacy and protection have been growing. Both government agencies and individual users have particularly been concerned on how their data is being collected and used on social media websites such as Facebook. Germany has taken action in response to such concerns and recently took a step against Facebook’s collection of data in a decision that outlawed Facebook’s entire advertisement regime.
The “Regulatory Sprint” to Value-Based Care: Adjusting Stark Law and the Anti-Kickback Statute
The current Deputy Secretary of the Department of Health and Human Services and former Loyola University Chicago School of Law professor Eric D. Hargan was sworn into his position as the Deputy Secretary on October 6, 2017. Since then, he has been working on assisting providers to help them better understand the intricacies of the Stark law by gathering provider concerns about present governing efforts. All of this work is being done in an effort to shift the healthcare system away from fee-for-service care and towards value-based care in what Hargan is calling the “Regulatory Sprint to Coordinated Care.” Hargan stated that “removing unnecessary government obstacles to care coordination is a key priority for this Administration.”
The Years Long Process to a Revised Common Rule and Implementation
The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.
“On Demand” Abortions: Protection for Women’s Rights or Expansion of Late-Term Abortions?
With the recent change of New York’s abortion law, legislators granted women the affirmative right to abortions under the state’s public-health law. Under the Reproductive Health Act, restrictions on abortion past twenty-four weeks are removed legalizing abortion up until the day of birth. This bill was passed on the 46th anniversary of the Roe v. Wade decision. The new bill comes as a reaction to the confirmation of conservative Supreme Court Justice Brett Kavanaugh, giving protection to women’s access to abortion if Roe v. Wade is overturned. Proving to be very controversial, the change has advocates and critics at odds with its potential future effects.