Article 28 of New York’s Public Health Law is the state statute that governs hospitals and most other healthcare facilities operating in New York. It requires any facility that provides medical diagnosis or treatment to hold an operating certificate issued by the state, meet standards for patient care and safety, and win approval from the Public Health and Health Planning Council before opening, expanding, or changing ownership. The Department of Health enforces the law through inspections, complaint investigations, and the certificate of need process.
What Counts as a Facility Under Article 28
The statute defines “hospital” far more broadly than the word suggests. It covers any facility primarily engaged in providing services, under a physician’s supervision, for diagnosing or treating disease, injury, or physical conditions. General hospitals are included, but so are public health centers, diagnostic centers, treatment centers, rural emergency hospitals, nursing homes, and midwifery birth centers.1New York State Senate. New York Public Health Law 2801 – Definitions
In day-to-day practice, the facilities most people encounter under Article 28 include ambulatory surgery centers, federally qualified health centers, dialysis clinics, and outpatient diagnostic and treatment centers.
Where the line gets fuzzy is between a private physician’s office and a regulated facility. The Department of Health looks at specific signals to decide: whether patients contact the facility rather than a specific doctor, whether the facility assigns physicians to patients, and whether billing comes from the organization rather than an individual practitioner. Each of those points toward Article 28 oversight.2Cornell Law School / Legal Information Institute. N.Y. Comp. Codes R. and Regs. Tit. 10 600.8 – Criteria for Determining the Operation of Diagnostic or Treatment Center Under Article 28 of the Public Health Law
This matters for medical groups and investors. If a healthcare operation looks and bills like a facility, the state can require compliance regardless of what the operator calls it.
The Operating Certificate and Who Can Get One
No one can run a covered healthcare facility in New York without first getting written approval from the Public Health and Health Planning Council. The council reviews applications for new facilities and major changes to existing ones. Operating without approval carries a civil penalty of up to $10,000 per violation, and the state can go to court to dissolve the corporation behind the unauthorized facility.3New York State Senate. New York Public Health Law PBH 2801-a
The operating certificate itself is the facility’s license. It spells out what services the facility may offer, its bed capacity when applicable, and any conditions or limits. Construction of any hospital, public or private, also needs the commissioner’s prior approval before ground is broken.
Character and Competence Review
Article 28 regulates not only what facilities do but who gets to run them. Before approving a new facility or a change in ownership, the council evaluates the “character and competence” of the proposed operators. The review covers the applicants’ track record in healthcare, their financial capacity to sustain the facility, and any prior compliance failures.3New York State Senate. New York Public Health Law PBH 2801-a
Applicants with a history of regulatory violations at other facilities, outstanding debts to state programs, or unresolved legal issues can expect close scrutiny and possible denial. The council can also weigh whether the proposed facility fits within the existing network of providers in the area, which feeds directly into the certificate of need process.
Certificate of Need for New Projects
Before a covered facility can be built, expanded, or buy major medical equipment, the project usually has to go through certificate of need (CON) review. The CON process is meant to confirm that proposed services match community need and to prevent duplicative investments that drive up costs without improving access.4New York State Department of Health. Certificate of Need (CON)
Projects that trigger CON review include:
- Establishing a new hospital, nursing home, home care agency, or diagnostic and treatment center
- Major construction and renovation at existing facilities
- Purchasing certain categories of expensive medical equipment
- Adding new types of services or significantly changing existing ones
New York is one of roughly 35 states that still maintain CON programs, and its version is among the more comprehensive. Filing fees can range from roughly $1,000 to $50,000 depending on the project’s scale, and review can take months. For large capital projects, the CON timeline is a significant planning factor.
Ongoing Patient Care and Safety Standards
An operating certificate commits the facility to continuing obligations in several areas.
Informed Consent
Providers at Article 28 facilities must disclose the reasonably foreseeable risks, benefits, and alternatives of any proposed treatment. A patient can bring a malpractice claim based on lack of informed consent if a reasonable person in the patient’s position would not have agreed to the treatment had they been fully informed. The law recognizes exceptions for emergencies and situations where disclosure itself would harm the patient.5New York State Senate. New York Public Health Law 2805-D – Limitation of Medical, Dental or Podiatric Malpractice Action Based on Lack of Informed Consent
Immunization Protocols
Hospitals must ask about the immunization status of every patient under 18 and make vaccines available for polio, mumps, measles, diphtheria, and rubella when needed. The duty falls on the facility’s administrative officer or whoever is in charge of patient intake.6New York State Department of Health. Public Health Law Article 28, Section 2805-h – Immunizations
Malpractice Prevention and Records
Article 28 facilities must maintain malpractice prevention programs and keep detailed records. Administrative requirements cover governance, quality assurance practices, and transparent operational procedures. These form the basis of what the Department of Health examines during inspections.7Justia. New York Public Health Law Article 28 – Hospitals
Staffing and Physical Plant
Facilities have to meet standards for personnel qualifications, staff-to-patient ratios, building safety, and physical infrastructure. The specifics vary by facility type and are spelled out in Title 10 of the New York Codes, Rules and Regulations, particularly Part 405 for hospitals.8Department of Health. Hospitals and Diagnostic and Treatment Centers (Clinics) in New York State
Where Federal Rules Overlap
Article 28 is state law, but it isn’t the whole picture. Most New York hospitals also participate in Medicare and Medicaid, which brings a separate layer of federal requirements including the Conditions of Participation, EMTALA emergency screening and stabilization duties, federal patient rights rules, and HIPAA privacy and security obligations.9eCFR. Part 482 – Conditions of Participation for Hospitals10Centers for Medicare & Medicaid Services (CMS). Emergency Medical Treatment and Labor Act (EMTALA)
A New York hospital typically needs both its Article 28 operating certificate and its Medicare provider agreement to function as most hospitals do. Losing either is potentially fatal to the business, and the two regimes run on parallel enforcement tracks.
What Happens When a Facility Falls Short
The Department of Health is the primary enforcer of Article 28, with authority under both the statute and Title 10 to inspect facilities, investigate complaints, and act when standards are missed.8Department of Health. Hospitals and Diagnostic and Treatment Centers (Clinics) in New York State
When violations are found, an operating certificate can be revoked, suspended, or limited, and the facility is generally entitled to a hearing first. The exception is when the Department finds that public health or patient safety is in imminent danger. In that case it can temporarily suspend or limit a certificate for up to 60 days with only written notice, and the hearing comes after the suspension. The Department can also block new patient admissions to a residential facility on similar emergency grounds.11New York State Senate. New York Public Health Law PBH 2806
Federal consequences can be equally serious. CMS can terminate a hospital’s Medicare provider agreement for noncompliance with participation conditions, failure to provide required records, civil rights violations, or refusal to allow facility inspections.12eCFR. Subpart E – Termination of Agreement and Reinstatement After Termination
Because state and federal oversight overlap, a single compliance failure can trigger both state action against the operating certificate and federal action against the Medicare provider agreement at the same time.