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What’s New with Regenerative Medicine?

September 21st, 2021 by

The field of regenerative medicine is ever expanding and evolving. As more viable options become available to patients, it’s important to stay abreast of regulation surrounding many of these applications.

In late 2019, the Food and Drug Administration (FDA) began informing the public of multiple reports of serious adverse events experienced by patients who were “treated” with non-FDA approved products marketed as containing exosomes. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. At the time of the 2019 warning, there were no FDA-approved exosome products and the FDA since then has not put out any new guidance. read more

IV Therapy Clinics: Take Note of IV Supervision Requirements

August 18th, 2021 by

As IV therapy clinics become more and more popular, the question to follow is, who can place the IV line and under what supervision? You would expect that first responders like Emergency Medical Technicians (EMT) would be able to start lifesaving IV lines on their own since they are the life support in between an incident and the emergency room. Contrary to what one might think is an “appropriate” ability or function of emergency personnel, under Florida law, EMTs are actually not permitted to place their IV lines on their own outside of an emergency situation. While there might be some very narrow exceptions, the general rule is clear in its prohibition. read more

All You Need to Know About Medical Devices Regulations

August 11th, 2021 by

Medical devices of all kinds are regulated by the Food and Drug Administration (FDA) in the United States.

Healthcare businesses that create medical device products are required to stay up-to-date with current medical device development regulation and law and to ensure that they are in compliance at all times.

It is also important for healthcare businesses that use medical devices to stay in the know when it comes to product regulation changes and updates.

What Are Medical Devices?

Medical devices include any component, accessory, part, machine, instrument, apparatus, implant, or in vitro reagent that is used for the purposes of diagnosing, preventing, mitigating, or treating a medical condition or disease.

Some combination products that are a device but also biologically inserted into the body and/or release a drug into the body are included in medical device laws.

Medical device regulations exclude drugs and certain software that manage administration of a medical office or support the storage of patient records.

What Is Pharmaceutical and Medical Device Law?

Medical device law and pharmaceutical device law codify medical devices according to different levels of risk and controls. For example, Class I medical devices are the lowest risk, and Class III medical devices have the highest risk.

Depending on the class of the medical device, medical device law and regulations may require:

  • Labeling that provides user information.
  • Medical device reporting of injuries or death that are related to use of the device.
  • Registering the business and all devices with the FDA.
  • Implementing a quality control system.
  • Avoiding misbranding or other misinformation.

Does Your Business Need Help Maintaining Medical Device Regulation Compliance?

Contact Florida Healthcare Law Firm today to discuss potential issues you may be facing due to medical and pharmaceutical device law. You’ll get the support you need to create a compliance plan and avoid any potential legal violations and legal restraints from the FDA.

Florida Long-Term Care Pharmacy Law

July 17th, 2021 by

Pharmacy law protects pharmacists, patients, the general public, and healthcare businesses in Florida through a number of different measures.

The details of these laws are updated regularly as new legislation is passed and old laws are changed.

It is important for healthcare industries in Florida to keep up with these changes, so they can protect their businesses and their patients.

How Does Pharmacy Law in Florida Protect Patients?

In some cases, patients may be prescribed a medication that does not work well with other medications they are taking.

The prescribing physician may not recognize that there could be a problematic interaction. Or, another physician prescribed the contraindicated medication and the second doctor isn’t aware.

Either way, a pharmacist in Florida is required by law to intervene if they see that a patient is trying to fill a script that could be lethal in combination with other prescribed medications.

How Does Florida Pharmacy Law Protect the Public?

Pharmacists in Florida are asked to fill fraudulent scripts every day by people seeking to divert addictive medications to the street.

Opioids like OxyContin and benzodiazepines like Xanax are among the most commonly abused prescription drugs, and pharmacists can often tell when the prescription is a fake.

Florida law gives pharmacists room to verify prescriptions before filling them in order to avoid filling fake scripts designed to put illicit drugs on the street.

Can Florida Pharmacy Law Protect Healthcare Businesses?

Absolutely. Laws are there to protect companies from lawsuits. By following them, healthcare businesses are better able to protect themselves and the people and businesses they serve.

Where Can I Find More Information?

If you would like to learn more about how pharmacy law in Florida could impact your business, contact us at the Florida Healthcare Law Firm today to set up a consultation.

Noncompetes, Healthcare and a New Executive Order

July 15th, 2021 by

On July 9, 2021, President Biden signed a far-reaching Executive Order that could have significant impact on the healthcare industry.  Under the Executive Order, President Biden:

– Encourages the Federal Trade Commission to ban or limit noncompete agreements, and to ban unnecessary occupational licensing restrictions;

– Supports the practice of state and tribal programs importing drugs from Canada;

– Directs HHS to increase support for generic and biosimilar drugs, and to issue a comprehensive plan to, “combat high prescription drug prices and price gouging” within 45 days; read more

How Medical Technology Impacts the Law

July 9th, 2021 by

Government agencies, universities, and private corporations invest heavily in the development of medical technology.

Not only does the latest research reveal new machines and options for treatment, but they can also improve on past technology and identify where past treatment methodologies may have erred.

This is good news for patients because it means that there is an active investigation into the best treatment practices for a range of disorders.

It is also good news for labs, healthcare businesses, pharmacies, and organizations involved in telemedicine and telehealth because they can stay at the forefront of the industry and better serve their clients.

How Does Medical Technology Impact the Law?

Healthcare law is in place to protect patients and their families as they undergo medical treatment, often for serious acute or chronic illnesses.

The laws help to ensure that they get the information they need, are treated fairly, and have access to all the best possible care.

They also help to protect healthcare businesses from frivolous lawsuits, misinformation, and targeting by other businesses that want to eliminate competition.

When medical technology changes — either it becomes obsolete or is improved — it is important that the laws quickly shift to include these changes so that all parties are aware.

Why Should Florida Healthcare Law Matter to Patients?

Florida healthcare law must evolve as medical technology changes so Florida patients and benefits are protected.

Keeping up with changes in medical technology within the law can help businesses to protect their interests.

Has My Business Been Impacted by Changes to Healthcare Law in Florida?

Every business is different, and depending on your area of concern, the services you provide, and how those services are impacted by changes to medical technology, your business will need to pivot differently than another might.

If you would like to speak to a legal expert on how changes in medical technology may impact your business practices and current contracts, reach out to Florida Healthcare Law Firm today to schedule a consultation.

4 Healthcare Laws That Are Protecting Patients’ Rights

June 14th, 2021 by

Healthcare laws exist to ensure that patients have the best care possible. If they don’t get the treatments they expect, these patients can lean on legislative acts to get relief. And regulatory agencies can step in and close down those groups that don’t follow healthcare acts, so no future patients are harmed.

Multiple healthcare acts exist, but in this piece, we’ll focus on those devoted to protecting the rights of patients.

4 Healthcare Laws to Know

Healthcare acts protecting patient privacy are likely well-known to most consumers and professionals. These are the laws we talk about in common conversations about the care we get when we visit the doctor.

This list of healthcare laws isn’t comprehensive, but it can give you an idea of the landscape regarding patient rights.

These are four healthcare laws to know:

  • ACA: The Affordable Care Act is commonly associated with insurance. Under the legislation, consumers can tap into programs to help them pay for medical expenses. But the law also includes regulations regarding preexisting conditions and covered care.
  • EMTALA: The Emergency Medical Treatment and Labor Act allows patients to head to the emergency room to get care even if they can’t pay the bill that comes when treatment is complete.
  • GINA: The Genetic Information Nondiscrimination Act ensures that people won’t face discrimination based on the results of genetic testing. If patients participate in a test and some issue is revealed, they can fight back if their employers penalize them for the results.
  • HIPAA: The Health Insurance Portability and Accountability Act includes rules that protect patient privacy. Patients can limit who sees their information, and they can ask for compensation if a breach occurs.

Again, this list of healthcare laws isn’t meant to be comprehensive. Instead, think of it as a research starting point.

Moving Beyond Healthcare Laws

Medical professionals must comply with applicable healthcare acts and laws. But they’re also guided by their ethics, including some versions crafted by oversight agencies.

For example, the American Medical Association has a formal Code of Medical Ethics that all physicians commit to. These rules cover how doctors relate to their patients, how they communicate medical news, and more.

Also, some healthcare professionals are guided by rules that originate at the state level. A hospital, for example, might have state laws regarding patient care. They can’t take in more cases than staffing rules allow even if they want to help more people.

If you’re confused about the legal landscape in your area, let us help. We have a skilled team that can help you understand your local laws. Contact us to find out more.

What Law Regulates the Healthcare Industry?

June 9th, 2021 by

Healthcare officials often chuckle when they see questions like, “Who regulates health care?” If only one law or organization oversaw every aspect of healthcare in this country, life would be a lot simpler for medical professionals and the organizations in which they work.

In reality, many different organizations are involved with regulating healthcare. And they enforce rules and regulations that may appear at the federal, state, or local level.

Who Regulates Health Care at the Federal Level?

The largest and most complex healthcare laws originate at the federal level. They are enforced by a variety of different agencies.

These three main federal agencies oversee healthcare organizations:

  • The U.S. Department of Health and Human Services: The Health Insurance Portability and Accountability Act (HIPAA) passed in 1996 includes multiple rules regarding patient privacy and recordkeeping. The DHS is responsible for enforcing those laws.
  • The U.S. Inspector General: Seated within the DHS, the Office of the Inspector General creates compliance documents to help hospitals and doctors comply with a bevy of federal laws.
  • The United States Department of Labor: The Occupational Safety and Health Administration creates rules that ensure a safe workplace. Since so many people work in healthcare, the rules are critical.

All of these groups offer guidance to help organizations comply with their rules and regulations. But compliance means paperwork. Hospitals and other care organizations must prove that they both understand and comply with the rules.

Who Else Is Involved in Regulating Health Care?

Healthcare providers are also required to abide by laws that originate from outside the federal system. The landscape varies from organization to organization.

A provider might have rules that originate in:

  • State agencies. Some states have rules regarding workers’ rights, patient access, and payment caps.
  • Federal payors, like Medicare. Some organizations must follow rules about payment options.
  • Private payors. Some companies like Blue Cross have rules about payments and access.
  • Nonprofit boards. Some hospitals and other care organizations are ruled by a board of directors. That group may also have compliance rules.

The landscape can be complex. An organization may face competing or conflicting rules regarding patient care and payments.

Navigate Health Care Industry Regulations

Healthcare providers need to focus on patient care, not paperwork. As one of the largest healthcare law firms in the nation, we can help. Let us assess your regulatory environment and help you come up with a comprehensive compliance plan. We can help you craft appropriate reports too, so you can prove you’re doing your job. Contact us to find out more.

What Is Tort Law in Healthcare?

June 6th, 2021 by

Tort laws in healthcare sound complicated. In reality, the underlying concepts are easy to understand.

A patient feels a doctor, medical facility, or other healthcare organization provided harmful services. That patient can use tort in healthcare to request compensation for the harms endured.

Tort Law in Healthcare Explained

If you don’t have a background in legal terms, understanding tort laws in healthcare takes a bit of time. But in general, know that a “tort” is a fancy way of saying “malpractice.”

Medical torts are triggered when a healthcare professional or organization causes patient injury. The aggrieved party files a suit and asks for compensation due to the damage.

These are a few of the issues that might trigger a tort in healthcare:

  • Diagnosis. A doctor misses a critical point and fails to issue a diagnosis, or the doctor interprets results improperly and misdiagnoses a patient.
  • Procedures. The doctor offers a treatment that isn’t needed, or the patient has a surgery performed on the wrong site.
  • Care. The patient is forced to leave the facility too quickly, or the patient doesn’t get proper instructions to help prevent complications.

This is a short, non-exhaustive list. In general, tort laws in healthcare are made to help patients fight back when something goes wrong with their care. Almost any complication you can think of could be part of tort law.

4 Legal Elements in Medical Torts

To win a case, the patient must show that the professional or organization was negligent when providing care, and that negligence caused an injury that deserves compensation.

Cases like this rest on four legal elements:

  1. Duty: The patient must prove the existence of a doctor-patient relationship. That connection requires the doctor to offer adequate care.
  2. Breach: The patient must prove that the doctor violated that relationship and the duty to provide care.
  3. Consequence: The patient must prove that the breach caused an injury.
  4. Damage: The patient must attach an appropriate monetary award to the breach.

In most cases, patients need competent legal representation. These aren’t issues they can win by acting as their own lawyers. And professionals need legal help too.

Assistance With Tort Law in Healthcare

If you’re facing a case like this, it’s critical to have an expert team on your side. You’ll need to gather information, talk coherently in court, and plead your case. Let us help you.

We focus exclusively on healthcare, and our team is ready to help. A consultation starts the process. Contact us to get started today.

What Is the New Healthcare Law?

June 2nd, 2021 by

Skim through social media posts and blogs, and you might believe that there’s a new healthcare law in the books. Otherwise, why would so many people ask questions like, “When does the new healthcare law take effect?” and “What is the new healthcare reform law?”

It’s critical for healthcare professionals to know how reform laws work and when they take effect. But it’s also very easy to get overwhelmed and confused by the ever-changing landscape.

Let’s break things down.

What Is the Affordable Care Act?

The health care reform law enacted in March 2010 is the Affordable Care Act (ACA). It’s also commonly known as Obamacare and the new healthcare law.

The ACA is far from new. Chances are, you’ve heard of it or billed patients using this form of insurance within the last decade. Key benefits of the legislation include:

  • Subsidies. People with lower incomes get help with premiums.
  • Penalties. Those who don’t get health insurance are dinged for that decision.
  • Expansions. Some states lowered Medicaid eligibility rules.
  • Marketplaces. People can sign up for health insurance through programs run at the state or federal level.

The bill contains many more provisions, including some involving preexisting conditions and others involving covered services. There’s a lot to unpack, and sometimes, consumers get lost in the details.

What Is the New Healthcare Law?

When people ask questions like, “When does the new healthcare law take effect?,” they’re reading news articles about changes.

The short answer: There is no new healthcare law.

The longer answer: The older legislation is changing. For example:

  • Expansions were enacted. The Biden administration allowed for special enrollments due to the pandemic. And some states reviewed their plans to increase Medicaid enrollments.
  • Premiums decreased. Cost-sharing programs announced by the Biden administration reduced costs, allowing some people to buy plans for about $10 per month.
  • Legislation could change things. A lawsuit filed in late 2020 asks the Supreme Court to consider whether the Affordable Care Act is unconstitutional.

In an environment like this, it pays to watch the news carefully and monitor how coverage and eligibility may change.

But it’s also wise to take the long view. Tiny shifts and ongoing legislative battles are unlikely to change your day-to-day work as a healthcare administrator. Don’t panic about the headlines.

Make Sense of the Affordable Care Act

As a boutique, full-service law firm focused exclusively on healthcare, we know the ins and outs of the ACA from the perspective of consumers, providers, and payers. We’d love to help you understand what the law means and how you should react to it. Contact us to find out more.