Tag: Legal

Why Federally Mandated Electronic Prescribing for Controlled Substances will Benefit Public Health

Why Federally Mandated Electronic Prescribing for Controlled Substances will Benefit Public Health

MedCity News

Although 2022 has brought on a greater sense of normalcy, the past few years have distracted us from one of the most overlooked epidemics plaguing healthcare: prescription drug abuse.
Before Covid-19 diverted attention away from this problem, President Trump signed on to the SUPPORT for Patients and Communities Act of 2018, instating sweeping legislation for initiatives to address the opioid epidemic. The bill, among other initiatives, requires electronic prescriptions for controlled substances (EPCS) for any covered part D drug. Although the official start of the mandate was delayed two years to January 1, 2023, the importance of this federal intervention cannot be…

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Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

MedCity News

Geographic atrophy, an eye disorder that starts as a loss of central vision and progressively worsens to total blindness, now has its first treatment. The FDA on Friday approved an Apellis Pharmaceuticals drug that slows the progression of this disease, which affects more than 1 million people in the U.S.
Approval of the Apellis drug, pegcetacoplan, covers all patients with geographic atrophy, a broad label that reflects the representative patient population tested in pivotal studies, Chief Medical Officer Caroline Baumal said during a Friday evening conference call. The Waltham, Massachusetts-based company plans to launch the drug in March, marketing the product under…

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PBMs Come Under Fire During Senate Hearing

PBMs Come Under Fire During Senate Hearing

MedCity News

Pharmacy Benefit Managers (PBMs) took a hit from lawmakers during a Thursday hearing held by the Senate Commerce Committee, with some questioning why the drug middlemen are even necessary.
“The way I see the situation on PBMs, I don’t know why the hell they even exist,” said Sen. Jon Tester, D-Montana. “They were set up with all the right reasons … But what I see them doing in my state, I don’t think the consumer gets much benefit and they’re shutting down small businesses on main street right and left and those are called our local neighborhood pharmacies.” The hearing discussed how…

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Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

MedCity News

A Chiesi Farmaceutici drug for a rare enzyme deficiency is now approved by the FDA, making it the first U.S. treatment for a disorder that leads to a range of cognitive and muscle problems.
The regulatory decision announced late Thursday covers the treatment of children and adults who have alpha-mannosidosis (AM), a disease caused by a genetic mutation that leads to defective or inactive forms of an enzyme called alpha-D-mannosidase. Chiesi’s drug, velmanase alfa, is an engineered version of that enzyme. The privately held Italian company will market its new FDA-approved drug as Lamzede, the same name for the product in Europe,…

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AI can be a big help to healthcare workers, but there are legal issues to consider

AI can be a big help to healthcare workers, but there are legal issues to consider

Healthcare IT news

As burnout among healthcare workers continues to be a major concern, the use of artificial intelligence, EHRs and other automation tools may be able to have a positive impact on hospitals and health systems.When it comes to artificial intelligence, some legal issues arise. That’s why we interviewed Carly Koza, an authority on this topic and Buchanan Ingersoll & Rooney associate. Buchanan Ingersoll & Rooney is a national law firm with 450 attorneys and government relations professionals across 15 offices representing companies including 50 of the Fortune 100.
Koza discusses what healthcare provider organizations should prepare for when it comes to growing AI…

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The Federal Trade Commission Accuses GoodRx Of Multiple Data Sharing Fails, Demands It Pay $1.5 Million Fine and Make Reforms

The Federal Trade Commission Accuses GoodRx Of Multiple Data Sharing Fails, Demands It Pay $1.5 Million Fine and Make Reforms

Healthcare IT Today

The Federal Trade Commission has cited telehealth and prescription drug discount provider GoodRx for sharing sensitive consumer health data with several advertising platforms, in violation of its own privacy promises to consumers.
The agency has filed a proposed order demanding that GoodRx pay $1.5 million in civil penalties for failing to let consumers know about unauthorized disclosures of its data to a list of advertiser platforms. including Facebook and Google.
The company, which is based in California, operates a digital health platform offering prescription drug discounts, telehealth visits and other health services. It captures a wide range of data from consumers who use…

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‘A Better Long-Term Solution’: How Health Systems Keep Workloads in the Cloud Secure

‘A Better Long-Term Solution’: How Health Systems Keep Workloads in the Cloud Secure

HealthTech Magazine

The evaluation process covers ­everything from compatibility to cost and the quality of customer service, but it also includes a comprehensive risk assessment led by the health system’s CISO.“Any vendor we’re potentially going to use must go through that assessment,” Meadows says. “We ask them about everything — their security infrastructure, their policy and procedure management, how they segment their networks — and then, based on their response, we can determine whether they’re a good fit or not.”
Cook Children’s also relies on a third-party system that allows it to check whether a particular vendor has experienced significant security issues in the…

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HHS Aims To Reduce Prescription Drug Costs Through 3 New Models

HHS Aims To Reduce Prescription Drug Costs Through 3 New Models

MedCity News

The U.S. Department of Health & Human Services (HHS) unveiled three new models Tuesday that will be tested by the CMS Innovation Center and aim to lower prescription drug costs. The models include access to $2 generic drugs.
The news is in response to President Joe Biden’s executive order issued in October, which directed HHS to find ways to lower prescription drug costs and improve access to drug therapies for those enrolled in Medicare and Medicaid health plans. The models are meant to build on the Inflation Reduction Act of 2022, which includes allowing Medicare to negotiate lower prescription drug prices for…

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Several Louisiana hospitals face online tracking lawsuits

Several Louisiana hospitals face online tracking lawsuits

Healthcare IT news

The class action lawsuits filed by Herman Herman & Katz allege Meta Pixel code potentially analyzed, gathered and shared the sensitive medical data of hundreds of thousands of patients across the LCMC Health Systems and Willis-Knighton Health System networks.WHY IT MATTERS
Pixel technology uses a Java tracking script to send an organization’s data to the technology owner, which in this case, is Meta, owner of Facebook, Instagram and WhatsApp. Tracked data could be shared with network marketing partners who target individuals with offers and advertisements.
The new class action lawsuit alleges that visitors to the health system websites may have had their protected…

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5 Biggest Healthcare MVP Challenges

5 Biggest Healthcare MVP Challenges

The Healthcare Guys

The healthcare industry currently faces many challenges, from meeting ever-changing patient demands to dealing with cyberattacks. The demand for efficient and secure IT solutions has never been greater. Healthcare MVPs are becoming increasingly popular as they offer a cost-effective way to bring innovative solutions to the market. However, they come with their own set of challenges to overcome.

Healthcare organizations need to develop products that meet the needs of their patients while providing a safe environment. We know that MVP is a great way to start because it gives you the opportunity to validate your idea fast, test the market…

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