Key Healthcare Regulatory Updates From 2024 and What to Expect in 2025

Regulations in the healthcare and environmental sectors are continually evolving, and 2024 was no different. Staying informed about the latest changes in health, safety, and waste management is crucial for ensuring that your organization and employees remain compliant with current requirements.

Here are some notable updates from the past year, along with a preview of potential developments for 2025.

Federal Regulatory Updates:

• Hazardous Waste Generator Improvements Rule: As of December 2024, 40 states and Puerto Rico have adopted the Hazardous Waste Generator Improvements Rule (HWGIR) from the Environmental Protection Agency (EPA). California was the latest and only state to adopt the rule in 2024, leaving 10 states yet to follow suit. Finalized in 2016, the rule addresses the management of chemical waste that is regulated as hazardous waste, not regulated medical waste (RMW). States with authorized programs must adopt regulations that are equally as stringent as, or more stringent than, the federal regulations. A key provision is the Small Quantity Generator (SQG) Re-Notification, which requires confirmation with the EPA by September 1, 2025.
  
  
• Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine: Both became effective on August 21, 2019, and the EPA gave states until July 2021 or 2022 to adopt the Hazardous Waste Pharmaceutical Rule, depending on if they had to go through a legislative process to adopt the rule or not. The rule includes a mandate that no hazardous waste pharmaceuticals, including controlled substances, can be disposed of into a sewer system. The EPA did not give a timeline for the nicotine exclusion part of the rule because it is less stringent than current regulation and thus does not have to be adopted by the States. This exclusion removes FDA-approved nicotine cessation items offered without a prescription, like gums, patches and lozenges, from EPA's list of acutely hazardous wastes (i.e. "P-list") In 2024, Washington, D.C. adopted the pharmaceutical rule, and Massachusetts adopted the nicotine exclusion, joining California and Maryland. 
  
  
• Universal Waste - Aerosol Cans: Effective February of 2020, the EPA added aerosol cans to the universal waste program under the federal Resource Conservation and Recovery Act (RCRA) regulations, seeking to reduce regulatory burdens on stores and other businesses that discard hazardous waste aerosol cans, while promoting recycling. In 2024, Massachusetts and South Dakota became the latest states to adopt this rule. 
  
  
• e-Manifest Rule Update: The EPA’s e-Manifest system, launched in 2018, tracks hazardous waste shipments electronically. By January 22, 2025, large quantity generators (LQGs) and small quantity generators (SQGs) were required to register in the system and designate a “Certifier” or “Site Manager.” The EPA has published a list of generators that do not have a “Certifier” or “Site Manager” in the e-Manifest system. It is important to note that is up to the generator to register themselves. Vendors cannot do this. Generators are expected to produce/show copies of manifests from the e-Manifest system during inspections. The e-Manifest system is the system of record. Paper copies are not required to be mailed to generators.
  
  
• Controlled Substance Destruction Alternatives to Incineration: In October 2023, the U.S. Drug Enforcement Administration (DEA) published an advance notice of proposed rulemaking and sought industry input on alternatives to incineration for rendering controlled substances non-retrievable. Comments were due in April 2024 but there have been no updates. The DEA is also proposing a reclassification of marijuana from Schedule I to Schedule III. Comments were due on July 22, 2024. The January hearing on the proposed rescheduling of marijuana was postponed. Check the DEA website for updates.

OSHA Updates

The Occupational Safety and Health Administration (OSHA) introduced key changes:

• Proposed Rule for an Emergency Response Standard: In February 2024, Federal OSHA issued a proposed rule for emergency responders. The rule is meant to replace the fire brigade standard and include other types of emergency responders, such as EMS and technical search and rescue. The goal is to protect them from a variety of occupational hazards. The latest update on the proposed rule is the public hearings, which concluded on December 4, 2024.
  
  
• Hazard Communication Standard (HCS):  In May 2024, OSHA issued a Final Rule that updates the Hazard Communication Standard to mostly align with revision seven of the global harmonized system. Revisions and additions include small package labeling requirements, and certain hazard information from trade secrets will be required on safety data sheets. In addition, updated precautionary statements along with more complete and accurate hazard information will be required on labels and safety data sheets. This rule was officially effective as of July 19, 2024, but the compliance deadlines are staggered over time for the new or updated requirements.
  
  
• Heat Injury and Illness Prevention: In August 2024, OSHA issued a proposed rule for heat injury and illness prevention. The rule is for both outdoor and indoor work settings. The goal is to prevent and reduce the number of occupational injuries, illnesses, and fatalities caused by exposure to hazardous heat. Some of the requirements will include a plan to evaluate and control heat hazards in the workplace along with other employer obligations and steps to take to protect employees. The last update on the proposed rule is the public comment phase, which ended on January 14, 2025.

HIPAA Updates

The Health Insurance Portability and Accountability Act (HIPAA) saw developments in:

• Reproductive Health Care Privacy Final Rule: In April 2024, Health and Human Services and the Office for Civil Rights issued a final rule for Reproductive Health Care Privacy. This final rule prohibits the disclosure of protected health information (PHI) related to lawful reproductive health care unless an individual's signed authorization is obtained, or the disclosure meets HIPAA's definition of "Required by Law.“ The final rule protects patient confidentiality and prevents medical records from being used against people for providing or obtaining lawful reproductive health care. Updated Privacy Policies should reflect this final rule as of December 30, 2024. In addition, for certain reproductive health care-related PHI requests, covered entities and business associates must now obtain a signed attestation from the requester, which states the request is not for a prohibited purpose. Updates to the Notice of Privacy Practices will be required by February 2026.

State Regulatory Updates 

Several states implemented notable changes:

• Michigan: In 2024, Michigan passed legislation that allows for sharps containers to be stored for up to 18 months by the generator, if less than 75% full. Prior regulations allowed for storage of up to 90 days, regardless of how full the containers were. Michigan also asked for assistance with updates to a document called “Medical Waste Directory.”
  
  
• Ohio Infectious Waste Rules: The Ohio EPA is considering reorganizing the rules into their own program chapter so they are easier to read and follow.  They also proposed storage timeframes for infectious waste and are prohibiting the storage of infectious waste in storage units. Finally, the Ohio EPA are allowing for the reuse of sharps containers.
  
  
• Alabama Medical Waste Rules: The Alabama Department of Environmental Management (ADEM) proposed amendments to its medical waste program rules. Changes are moving along in two phases. The first phase moved requirements around but had no substantive changes. It became effective on February 14, 2025. Phase two includes a proposed registration process for medical waste generators. They are also proposing new storage times for generators. Draft rules are expected by March or April 2025.  

What to Expect in 2025

Key areas to monitor include:

• State adoption of EPA rules: Continued adoption of the various rules discussed above.
• State regulated medical waste regulation updates: Potential changes or updates at the state level. To stay updated, check your state’s registers and/or relevant agency websites.  
• Potential updates to HIPAA Privacy Rule: HIPAA Privacy Rule is subject to change to account for new situations and resources.

With the regulatory landscape always evolving, healthcare facilities need to be prepared. Learn how Stericycle can help with your compliance efforts in 2025.