Legal basis and policy
- These rules are issued to implement Republic Act No. 4226 (Hospital Licensure Act) consistent with Executive Order No. 102 (Redirecting the Functions and Operations of the Department of Health) (Section 2).
- These rules are promulgated to protect and promote public health by ensuring rights to quality health service appropriate to the level of care through regulation of hospitals and other health facilities (Section 3).
Coverage and regulated entities
- The rules apply to all government and private hospitals and other health facilities (Section 4).
- The rules govern the registration, licensure, and operation of hospitals and other health facilities (Section 1).
- The rules apply to any individual, partnership, corporation, association, or organization operating a hospital or other health facility when evaluating violations and disciplinary consequences (Section 17).
Key definitions
- A hospital is a health facility for the diagnosis, treatment and care of individuals suffering from deformity, disease, illness or injury, or needing surgical, obstetrical, medical or nursing care (Section 6).
- A hospital is an institution with bassinets or beds for 24-hour use or longer for the management of conditions including maternity cases, and abnormal physical and mental conditions (Section 6).
Classification of hospitals and facilities
- Hospitals and other health facilities are classified by type:
- Government: operated and maintained partially or wholly by the national, provincial, city or municipal government, or other political unit, or by a department, division, board, or agency (Section 7.1.1).
- Private: privately owned and established/operated with funds through donation, principal, investment, or other means by any individual, corporation, association, or organization (Section 7.1.2).
- Hospitals are also classified by scope of services:
- General: provides services for all types of deformity, disease, illness or injury (Section 7.2.1).
- Special: primarily engaged in specific clinical care and management, with a first level referral hospital, second level referral hospital, third level referral hospital, or infirmary allowed to provide special clinical services (Section 7.2.2).
- Service capability is classified as follows:
- First Level Referral Hospital (non-departmentalized):
- Provides clinical care and management on prevalent diseases in the locality (Section 7.3.1.1).
- Clinical services include general medicine, pediatrics, obstetrics and gynecology, surgery and anesthesia (Section 7.3.1.2).
- Provides appropriate administrative and ancillary services including clinical laboratory, radiology, pharmacy (Section 7.3.1.3).
- Provides nursing care for patients requiring intermediate, moderate and partial category of supervised care for 24 hours or longer (Section 7.3.1.4).
- Second Level Referral Hospital (departmentalized):
- Provides clinical care and management on prevalent diseases in the locality, and particular forms of treatment, surgical procedure, and intensive care (Section 7.3.2.1).
- Provides clinical services of the first level plus specialty clinical care (Section 7.3.2.2).
- Provides administrative and ancillary services including clinical laboratory, radiology, pharmacy (Section 7.3.2.3).
- Provides nursing care of the first level plus total and intensive skilled care (Section 7.3.2.4).
- Third Level Referral Hospital:
- Teaching and training hospital providing clinical care and management on prevalent diseases, plus specialized and sub-specialized forms of treatment, surgical procedure and intensive care (Section 7.3.3.1).
- Provides clinical services of the second level plus sub-specialty clinical care (Section 7.3.3.2).
- Provides administrative and ancillary services including clinical laboratory, radiology, pharmacy (Section 7.3.3.3).
- Provides nursing care of the second level plus continuous and highly specialized critical care (Section 7.3.3.4).
- Infirmary: provides emergency treatment and care for the sick and injured, plus clinical care and arrangement to mothers and newborn babies (Section 7.3.4).
- Birthing Home: provides maternity service or prenatal and post natal care, normal spontaneous delivery, and care of newborn babies (Section 7.3.5).
- Acute-chronic Psychiatric Care Facility: provides medical service, nursing care, pharmacological treatment, and psychosocial intervention for mentally ill patients (Section 7.3.6).
- Custodial Psychiatric Care Facility: provides long-term care, including basic human services such as food and shelter, to chronic mentally ill patients (Section 7.3.7).
- First Level Referral Hospital (non-departmentalized):
Regulatory agency and licensing concepts
- The Department of Health, through the Bureau of Health Facilities and Services in the Office for Health Regulation, exercises regulatory functions (Section 5).
- A license is a formal authorization issued by the Department of Health to an individual, partnership, corporation, or association to operate a hospital and other health facilities (Section 8).
- A license is a prerequisite for accreditation by any accrediting body recognized by the Department of Health (Section 8).
- The Bureau of Health Facilities and Services evaluates compliance with licensing requirements for all hospitals and other health facilities (Section 9.4).
- The Bureau is supported by internal structures:
- The Bureau shall create a Hospital Establishment Review Committee for prompt review of applications for permit to construct (Section 10.3).
- The Bureau shall create Hospital Licensing Team(s) for prompt inspection and review for initial license to operate (Section 10.4).
- The Center for Health Development shall create a Hospital Licensing Team(s) for prompt action on renewal applications (Section 11.5).
Licensing rules: permit to construct and license to operate
- Permit to Construct is required for:
- Construction of a new hospital or other health facility;
- Alteration, expansion, or renovation of an existing hospital or other health facility;
- Change in classification; or
- Increase in bed capacity (Section 10.1).
- A permit to construct is a prerequisite for a license to operate (Section 10.1).
- Permit to construct application requires the following documents (Section 10.1.1):
- Letter of Application to the Director of the Center for Health Development;
- Letter of Endorsement to the Director of the Bureau of Health Facilities and Services;
- Form No. 1-01: Application for Permit to Construct notarized;
- Four (4) Sets of Site Development Plans and Floor Plans signed and sealed by an Architect and/or Engineer.
- For construction or change in classification, additional documents include:
- Feasibility Study;
- Zoning Certificate or Location Clearance from the City/Municipal Planning and Development Office;
- DTI/SEC Registration (for private hospitals/other health facilities);
- Enabling Act (for national government hospitals/other health facilities);
- Approved Board Resolution (for local government hospitals/other health facilities).
- Permit to construct application procedures are:
- Applicant requests relevant information and prescribed forms from the Center for Health Development under whose jurisdiction the proposed facility is located (Section 10.1.2.1).
- Applicant accomplishes required documents and submits them to the Center for Health Development for endorsement to the Bureau (Section 10.1.2.2).
- The Bureau reviews and approves or disapproves issuance of the permit (Section 10.1.2.3).
- If disapproved, the Bureau returns documents with findings/recommendations; applicant revises and submits revised documents for another review (Section 10.1.2.4).
- If approved, the Bureau issues the permit; applicant pays the corresponding fee to the Cashier of the Department of Health in person or through postal money order (Section 10.1.2.5).
- License to Operate is required for operation and is secured after construction and completion (Section 10.2).
- Initial license to operate application requires the following documents (Section 10.2.1):
- Letter of Application and Request for Inspection to the Director of the Center for Health Development;
- Letter of Endorsement to the Director of the Bureau of Health Facilities and Services;
- Form No. 2-01: Application for Registration and Issuance of License to Operate notarized;
- List of Personnel notarized;
- List of Equipment/Instrument;
- Photo Album of the exterior and interior of the hospital or other health facility.
- Initial license procedures are:
- Applicant requests relevant information and prescribed forms from the Center for Health Development in person or through mail, email or Internet (Section 10.2.2.1).
- Applicant accomplishes required documents and submits them to the Center for Health Development for endorsement to the Bureau; upon filing, the applicant pays corresponding fees for registration and license to the Cashier of the Department of Health in person or through postal money order (Section 10.2.2.2).
- The Bureau conducts ocular inspection in accordance with licensing requirements (Section 10.2.2.3).
- The Bureau approves or disapproves issuance (Section 10.2.2.4).
- If disapproved, the Bureau sends findings and recommendations; the applicant requests another inspection (Section 10.2.2.5).
- If approved, the Bureau registers the facility and issues an initial license to operate (Section 10.2.2.6).
- Review structures (membership composition) are established as follows:
- Establishment Review Committee meets once a week or when necessary and includes a Chairman (Assistant Director, Bureau of Health Facilities and Services), Vice-Chairman (Head, Standards Development Division), and members including an Architect, Engineer, Health Physicist, Nurse, Pathologist or Medical Technologist, Pharmacist, and Physician (Section 10.3.2).
- Licensing Team(s) includes a Team Leader (Physician) and members including an Architect or Engineer, Health Physicist, Nurse, Pathologist or Medical Technologist, and Pharmacist (Section 10.4.2).
Renewal and inspection requirements
- Licenses to operate must be renewed every year (Section 11.1).
- Inspection may be done every other year (Section 11.1).
- Renewal application must be filed ninety (90) days before the expiry date with the Center for Health Development under whose jurisdiction the hospital or other health facility is located (Section 11.2).
- Renewal application requires:
- Letter of Application and Request for Inspection to the Director of the Center for Health Development (Section 11.3.1);
- Form No. 3-01: Application for Renewal of License to Operate notarized (Section 11.3.2);
- List of Personnel notarized (Section 11.3.3);
- List of Equipment/Instrument (Section 11.3.4).
- Renewal procedures are:
- Applicant requests forms and information from the Center for Health Development in person or through mail, email or internet (Section 11.4.1).
- Applicant submits documents to the Center; upon filing, the applicant pays corresponding fees for renewal of license to operate to the Cashier of the Center for Health Development in person or through Postal money order (Section 11.4.2).
- The Center conducts ocular inspection (Section 11.4.3).
- The Center approves or disapproves issuance (Section 11.4.4).
- If disapproved, findings and recommendations are sent; applicant requests another inspection (Section 11.4.5).
- If approved, the Center issues a license to operate (Section 11.4.6).
- The Center must submit a quarterly report of all renewal applications to the Bureau, including name of facility, location, type of application, scope of work, findings and recommendations (Section 11.6).
- Inspections require:
- Regular inspections of all hospitals and other health facilities, with records made available to determine compliance (Section 12.1).
- The Bureau or the Center is allowed to inspect at an appropriate time (Section 12.2).
- Facilities must make available records for inspection (Section 12.3).
- The Director of the Center for Health Development and the Chief of the Provincial/City/Municipal Health Office must report unlicensed hospitals and violations to the Bureau (Section 12.4).
- Monitoring requires:
- Regular monitoring of all hospitals and other health facilities, with records made available to determine compliance (Section 13.1).
- The Bureau may monitor at any given time (Section 13.2).
- Facilities must make records available for monitoring (Section 13.3).
Fees and required technical compliance
- Non-refundable fees are charged for:
- Application for permit to construct, registration, and license to operate a government and private hospital and other health facilities (Section 15.1).
- Application for renewal of license to operate (Section 15.2).
- Fees are paid to the Cashier of the Center for Health Development (Section 15.3).
- Fees follow the Department of Health’s current prescribed schedule of fees (Section 15.4).
- Licensing requirements include compliance with planning/design and operational standards:
- Planning and design must comply with prescribed guidelines (Annex 1) (Section 9.1).
- Management of service capability, personnel, equipment, and physical plant must conform to prescribed guidelines (Annex 2) (Section 9.2).
- Construction/alteration/expansion/renovation must comply with:
- Floor plans prepared by a duly licensed Architect and/or Civil Engineer and approved by the Bureau of Health Facilities and Services (Section 9.3.1);
- Architectural/engineering drawings based on approved floor plans, specifications, building permit, and fire safety permit prepared by a duly licensed Architect and/or Civil Engineer and approved by the Office of the Building Official and the Bureau of Fire Protection in the locality (Section 9.3.2).
- Hospitals must meet core physical and operational guidance in Annex 1 and Annex 2, including but not limited to:
- Annex 1 functional, safety, sanitary, privacy, fire protection, parking, zoning, signage, circulation, and space area requirements including minimum one (1) parking space for every twenty-five (25) beds (Annex 1, item 18).
- Annex 2 staffing, governance, administrative, clinical, nursing, ancillary services, equipment, written policies, and quality assurance program requirements.
Terms, conditions, lapse, and transfer limits
- No license to operate is issued unless the facility has:
- A permit to construct secured prior to construction/alteration/expansion/renovation/increase in bed capacity; and
- License for operation of clinical laboratory, radiology and pharmacy (Section 16.1).
- A permit to construct lapses and fees paid are forfeited when authorized work does not commence within 365 days from date of issuance, or is abandoned during the specified period (Section 16.2).
- A license to operate is granted subject to specific conditions and limitations established during inspection (Section 16.3).
- License lapse for non-renewal:
- A license not renewed for two (2) years is considered lapsed and registration is cancelled; a new application is required before the facility may operate (Section 16.4).
- License transfer restriction:
- The license and any right under it cannot be assigned or transferred directly or indirectly to any party without the written consent of the Director of the Bureau of Health Facilities and Services (Section 16.5).
- Notification and relocation/ownership changes:
- The Bureau must be notified of any change in management, name or ownership; transfer of location requires a new application for permit to construct, registration, and issuance of license to operate (Section 16.6).
- Substantial change reporting:
- Failure to report in writing within fifteen (15) days of any substantial change in the condition of the license is a basis for suspension or revocation (Section 16.7).
- Branch and separate building rule:
- Separate license is required for all hospitals or branches maintained in separate buildings in the same premises (Section 16.8).
- Display and availability:
- The license must be placed in an area readily seen by the public and a copy of the rules and regulations must be readily available for hospital personnel guidance (Section 16.9).
- License expiry:
- The license expires on the date of anniversary of issuance (Section 16.10).
Violations, suspension/revocation, closure, and penalties
- Violations that include acts by any operating individual or entity include:
- Making substantial alteration or renovation without securing a permit to construct (Section 17.1).
- Material false statements in the application (Section 17.2).
- Change of location, management, name or ownership without informing the Bureau in writing (Section 17.3).
- Refusing to allow inspection at an appropriate time (Section 17.4).
- Refusing to allow monitoring at any given time (Section 17.5).
- Refusing to discharge patients or their relatives, refusing to release cadavers, and refusing to issue a duly accomplished death certificate for non-payment of hospital bills (Section 17.6).
- Refusing to admit patients for lack of capacity to pay (Section 17.7).
- Failure to correct deficiencies after due notice and required by the Bureau or the Center (Section 17.8).
- Investigation and hearing:
- When charges or complaints are filed against a hospital/health facility or its personnel for violating Republic Act No. 4226 or these rules, the Bureau investigates and verifies guilt (Section 18).
- If found violating, the Director of the Bureau suspends the license for a definite or indefinite period or revokes the license, without prejudice to criminal action (Section 18).
- Revocation/suspension grounds:
- The Director suspends or revokes a license upon violation of Republic Act No. 4226 or the rules issued in pursuance (Section 19).
- The Bureau notifies the facility or its personnel by registered mail with particular reasons for denial or revocation (Section 19).
- Closure:
- The Bureau must immediately close all hospitals and other health facilities without a license to operate and may seek assistance of any government agency to enforce closure (Section 20).
- Criminal penalty for establishing/operating without required authorization or for violating supervision:
- Upon conviction, the penalty is not more than PHP 500.00 for the first offense and not more than PHP 1,000.00 for each subsequent offense (Section 21).
- Each day that a facility operates after the first conviction constitutes a subsequent offense (Section 21).
Appeals, lists, technical assistance, and moratorium
- Appeals:
- Any hospital or other health facility, or any of its personnel aggrieved by a Bureau decision may file a notice of appeal within thirty (30) days after receipt of notice of the decision, with the Office of the Secretary, and serve a copy on the Bureau (Section 22).
- The Bureau must promptly certify and file a copy of the decision including the hearing transcript with the Office of the Secretary for review (Section 22).
- The Office of the Secretary’s decision is final and executory (Section 22).
- Publication:
- A periodically published list of licensed hospitals and other health facilities, according to classification, must be made available to any person for a legitimate purpose (Section 23).
- Technical assistance and enforcement support:
- The Bureau develops capability of the Center for Health Development on enforcement of these rules (Section 14.1).
- The Bureau provides technical assistance and advisory services to the Center for Health Development, Local Government Unit, and Private Institution on compliance with licensing requirements (Section 14.2).
- Moratorium and transition support:
- The Center for Health Development prepares resources to execute renewal of license to operate within two (2) years from effectivity (Section 26).
- During that period, the Bureau assists the Center in renewal of license to operate Second and Third Level Referral Hospitals (Section 26).