Example of healthcare regulations
ISO (International standardization Organization)
ISO, the International Organization for Standardization. ISO is an independent, non-governmental organization. ISO is a global network of national standards bodies with one member per country. ISO’s job is to make International Standards. ISO is coordinated by a Central Secretariat in Geneva, Switzerland. ISO provides a platform for developing practical tools through common understanding and cooperation with all stakeholders. ISO health standards ensure consistency. Healthcare providers, national governments and manufacturers benefit from not having to comply with multiple specifications and requirements for different markets. ISO standards are strategic tools that help businesses gain a competitive advantage through products and services that are safe, reliable and trustworthy. Regulators can rely on trusted internationally harmonized solutions, which are continually reviewed and improved to provide the technical foundation for market-friendly regulations that meet citizens’ expectations. ISO standards provide tools to assess and evaluate conformity, affording a solid technical base for health legislation. ISO standards seek to harmonize the healthcare sector to reduce costs, thereby facilitating access to care and increasing efficiency. Below is a selection of ISO technical committees dedicated to improving the safety and quality of healthcare worldwide. Quality management and risk management ISO standards for health help to ensure the safety and effectiveness of health practices and products through proficient quality and risk management. ISO/TC 210, Quality management and corresponding general aspects for medical devices This health committee develops standards for the application of risk management to the design and manufacture of medical devices. It also covers small-bore connectors used to connect medical devices, such as tubing, syringes and other accessories delivering fluids and gases for patient care. ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems This health committee provides a practical approach to reducing error in medical laboratories through risk management and continual improvement. Current standards cover laboratory safety, analytical performance and quality assurance.
Future areas of focus include the management of bio risks, i.e. risks originating from the handling of biological agents and toxins. Medical devices ISO/TC 194, Biological and clinical evaluation of medical devices This ISO technical committee standardizes biological test methods for the evaluation of medical and dental materials and devices prior to their release for commercial use. ISO/TC 198, Sterilization of healthcare products This health committee lays down the requirements for sterilization processes, sterilizing equipment, washer disinfectors and ancillary products used to ensure the satisfactory sterilization of healthcare products. Optics and photonics Optics and photonics* are “ enabling technologies ” that not only influence information technology, telecommunications, lighting and energy, but also have innovative applications in healthcare and life sciences through advanced laser technology and automation. • ISO/TC 172, Optics and photonics This health committee helps develop uniform terminology and test methods for handling safety issues properly. * ISO standards in this field span a range of sectors from highly sophisticated systems down to “ simple ” semi-finished products or components, such as medical/ surgical lasers, bar-code readers, sensors and other electro-optical instruments. Oral health • ISO/TC 106, Dentistry A major sector in ISO is healthcare technology. Standardization in oral healthcare includes terminology, methods of test and specifications applicable to materials, instruments, appliances and equipment used in all branches of dentistry. Surgical implants • ISO/TC 150, Implants for surgery This health committee sets out specifications and test methods for the safety and effectiveness of surgical implants that are inserted into the body for diagnostic or therapeutic purposes. Healthcare organization management Healthcare services management involves a lot of moving pieces, including health facilities, medical equipment, staff and patients. Good organization is essential to managing these multiple and interdependent functions. • ISO/TC 304, Healthcare organization management Drawing on best practice and advances in scientific research, this health committee develops standards for the classification, terminology, nomenclature, management practices and metrics covering non-clinical operations of healthcare entities. It is currently working on three standards covering the vocabulary of healthcare management (ISO 22886), hand hygiene practices (ISO 23447) and patient-centred staffing (ISO 22956). E-health technologies The standardization of health informatics means that data can be collated more efficiently and shared more effectively. • ISO/TC 215, Health informatics This health committee strives to achieve compatibility and interoperability between independent systems in the use of health-related data, information and knowledge to support all
Saudi Healthcare Regulations
CBAHI (Mandatory)
The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) is the official agency authorized to grant accreditation certificates to all governmental and private healthcare facilities operating today in Saudi Arabia. CBAHI has emerged from the Saudi Health Council as a non-profit organization. The principal function of CBAHI is to set the healthcare quality and patient safety standards against which all healthcare facilities are evaluated for evidence of compliance.
It is mandatory for all public and private healthcare delivery facilities (hospitals, polyclinics, blood banks and medical laboratories) in Saudi Arabia to comply with national standards set by CBAHI and obtain its accreditation through a survey process set forth by the Center.
Mandatory status of CBAHI accreditation
In late 2013, when a Cabinet of Ministers Decree called for changing CBAHI’s official name to the “Saudi Central Board for Accreditation of Healthcare Institutions”, it also mandated the national accreditation by CBAHI on all healthcare facilities. In addition, the Ministry of Health is mandating CBAHI accreditation as a prerequisite for renewal of the operating license – a step towards encouraging more participation in this ambitious national initiative.
Healthcare Compliance Advisory
CBAHI Standards
National standards set the best measurable, realizable and assessable performance.
A standard is a statement of excellence, or an explicit predetermined expectation that defines the key functions, activities, processes and structures required for healthcare facilities to assure the provision of safe and quality care and services. Standards are developed by peer experts in the field and it is against the standards that conformity of the healthcare facility is evaluated. Simply stated, the standard describes a healthcare facility’s acceptable performance level. Broadly speaking, CBAHI’s standards are of three major types depending on which area they are addressing.
- Structure standards address the system’s inputs, such as the hospital beds available, the manpower, the design of the hospital building, the availability of personal protective equipment for health workers, such as gloves and masks, and the availability of equipment and supplies, such as microscopes and laboratory reagents.
- Activity and procedure standards (procedural) address the clinical and administrative activities or interventions carried out within the hospital in the care of patients or in the management of the hospital or its staff. Examples include patient assessment, patient education, medication administration, and the like.
- Outcome standards look at the assessment of the benefits of an intervention and whether the expected purpose of the activity was achieved. They provide information about whether predicted outcomes are being realized. Examples of outcome indicators include mortality rates, foreign object retained after surgery, air embolism, blood incompatibility, pressure ulcers, falls, vascular catheter-associated infection, catheter-associated urinary tract infection, and manifestations of poor glycemic control.
- The standard development is a regular cyclic process integrated to the CBAHI strategic plan and largely based on national interest and needs assessment. The CBAHI standard development department with Standard development committees that include in its membership subject matter experts together with task forces formed for the purpose of development are chartered with development / revision / modification of standards. The development is governed by policies and passes through planned - time framed processes such as drafting, pilot testing, field review, national consensus and approvals together with intended users communication and orientation before implementation. All through the standards implementation period, feedbacks are collected from users (healthcare facilities), surveyors, healthcare community and public to serve in the development/revision and modification ongoing process.
Healthcare Compliance Advisory
US Healthcare Regulations
The Joint Commission Program (Optional)
The Joint Commission Program (Optional) The Joint Commission standards are the basis of an objective evaluation process that can help health care organizations measure, assess, and improve performance. The standards focus on important patient, individual, or resident care and organization functions that are essential to providing safe, high quality care. The Joint Commission’s state-of-the-art standards set expectations for organization performance that are reasonable, achievable, and survey-able. Achieving Joint Commission accreditation demonstrates a commitment to continuous improvement in patient care. Joint Commission accreditation tells your patients you're committed to providing safe, high quality care — time after time.
US Healthcare Regulations
Healthcare Quality Improvement Act of 1986 (HCQIA)
The Healthcare Quality Improvement Act (HCQIA) provides immunity for medical professionals and institutions during conduct assessments. The law originated partially due to a Supreme Court ruling involving abuse of the physician peer review process. To date, HCQIA continues to evolve as the act arises in courtrooms and justices deliver new rulings. Legislators enacted the law to protect medical professionals from peer review-related lawsuits and to encourage physicians to file official complaints after encountering unprofessional and dangerous peer conduct.
Patient Safety and Quality Improvement Act (PSQIA) of 2005
The Patient Safety and Quality Improvement Act (PSQIA) protects health care workers who report unsafe conditions. Legislators created the law to encourage the reporting of medical errors, while maintaining patients’ confidentially rights. To ensure patient privacy, the HHS levies fines for confidentially breaches. The law also authorizes the Agency for Healthcare Research and Quality (AHRQ) to publish a list of patient safety organizations (PSOs) that record and analyse patient safety data. The Office for Civil Rights (OCR) enforces the law among national health care facilities.
EU Healthcare Regulations
European Union
The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. Two new regulations of the preceding on medical devices and in vitro diagnostic medical devices entered into force in May 2017. With effect from 26 May 2021, Regulation (EU) 2017/745Search for available translations of the preceding of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EECSearch for available translations of the preceding on active implantable medical devices and Council Directive 93/42/EEC of the preceding on medical devices. With effect from 26 May 2022, Regulation (EU) 2017/746Search for available translations of the preceding of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices replaces Directive 98/79/EC of the European Parliament and of the Council of the preceding on in vitro diagnostic medical devices after a transition period. Read the press release from the European Commission of the preceding In order to get ready for the new regulations of the preceding the Commission prepared detailed information for all actors involved.
UK Healthcare Regulations
The NHS Long Term Plan Implementation Framework
The NHS Long Term Plan, published in January 2019, set out a 10-year practical program of phased improvements to NHS services and outcomes, including a number of specific commitments to invest the agreed NHS five-year revenue settlement. This Implementation Framework sets out the approach Sustainability and Transformation Partnerships (STPs)/Integrated Care Systems (ICSs) are asked to take to create their five-year strategic plans by November 2019 covering the period 2019/20 to 2023/24. These plans should be based on realistic workforce assumptions and deliver all the commitments within the Long-Term Plan.
Singapore Healthcare Regulations
The PHMC Act
The PHMC Act and its subsidiary legislation promulgated the minimum standards for maintaining a healthcare service. These standards relate mainly to the general maintenance of the facilities, medical record keeping, drug storage, infection control, medical and nursing manpower, and fire safety.
The HCSA
The HCSA was enacted in January 2020 to replace the current PHMCA with a more flexible and modular services-based licensing regime, and to enhance patient welfare, safety, and continuity of care. The HCSA will be implemented for Licensees in three phases, outlined in Annex A. In the interim, existing PHMCA Licensees not rolled over into HCSA will continue to be subject to the prevailing Regulations and requirements under the PHMCA.
Singapore’s HEALTHCARE CYBERSECURITY ESSENTIALS (HCSE)
In the Ministry of Health (MOH)’s Cybersecurity Advisory to all licensees under the Private Hospitals and Medical Clinics Act (PHMCA) on 8 Feb 2021, MOH shared a set of cybersecurity measures in response to the SolarWinds supply chain attack to safeguard and ensure the integrity of personal and medical data within medical records, so as to be compliant with the PHMC Regulations and the Personal Data Protection Act (PDPA). MOH also indicated that they will be releasing a set of guidance to help licensees improve the cybersecurity of their IT systems.
JAPAN Healthcare Regulations
JAPAN’S PMD ACT
As of 25 November 2014, the Japanese Pharmaceutical Affairs Law (also known as PAL) was revised, with its title changed to the “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (abbreviated as the PMD Act). The PMD Act provides the legal framework for the regulation of medical devices, in vitro diagnostic reagents, pharmaceuticals, drugs and cosmetic products as well as regenerative and cellular therapy products in the Japanese market. Administration and oversight of the PMD Act legal framework is the responsibility of Japan’s Ministry of Health, Labour and Welfare (MHLW). Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory agency that works together with MHLW. It conducts scientific assessments of marketing application of pharmaceuticals and medical devices, monitoring their post marketing safety.
Australia Healthcare Regulations
Australian Department of Health
Australian Department of health set standards for the products and services you use and we then check regularly to make sure those standards are being met. For example:
The Therapeutic Goods Administration Australia’s largest regulator the
Therapeutic Goods Administration looks at prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products
The Aged Care Quality and Safety Commissioner The Aged Care Quality and Safety Commissioner looks into the quality of care or services being delivered to people receiving aged care services
Ombudsman The Private Health Insurance Ombudsman protects the interests of private health insurance consumers. Regulation activities can include accreditation of individuals and organisations, monitoring, reviews, investigations and complaints.
Abu Dhabi Healthcare Regulations
UAE, Abu Dhabi Department of Healthcare (DOH)
DOH launched new regulations in the past few years applicable to the healthcare providers in different domains such as (JDC)the data certification for the payers/payee, (AAMEN) for the information security and the data privacy. Abu Dhabi Healthcare Information Security Program (ADHICS) The Abu Dhabi Healthcare Information Security Program - AAMEN, aims to ensure that all healthcare facilities in the Emirate of Abu Dhabi are compliant with the information security and data privacy standards required to protect sensitive patient healthcare data. The program allows Department of Health to evaluate healthcare facilities for their compliance against the highest standards of information security, and provides the support needed to achieve world-class patient data privacy, securing the confidentiality of health information in its different forms, maintaining its accuracy and ensuring its accessibility.
THE STRATEGY:
Abu Dhabi Healthcare Information and Cyber Security Strategy As part of AAMEN program the Department of Health has released Abu Dhabi Healthcare Information and Cyber Security Strategy to serve as a framework that defines the important principles that guide the unique and comprehensive approach to continue enhancing the preparedness of Abu Dhabi’s healthcare sector to mitigate cyber threats securely and effectively. Department of Health is the first entity in the region to develop such strategy for the healthcare sector. It is part of ongoing efforts to further enhance information infrastructure of the healthcare sector. The new strategy will contribute to putting in place a cohesive and proactive response framework related to the current and future healthcare cybersecurity challenges for the Emirate of Abu Dhabi, while remaining focused on digital transformation through enabling technology, innovation and AI adoption in the healthcare sector of the emirate.
The strategy consists of six key areas of focus: Cyber Security Governance Cyber Security Resilience Cyber Security Capabilities Cyber Security Partnerships Cyber Security Maturity Cyber Security Innovation AAMEN Program Initiatives As part of AAMEN Program, Department of Health has developed the following instruments setting the minimum cybersecurity protection requirements stakeholders must comply with…
ADHICS
ADHICS stands for “Abu Dhabi Health Information and Cyber Security” Healthcare facilities are required to meet the standard requirements in order to integrate within the new 'Malaffi' system. The standard is mandatory for licensing healthcare practitioners and facilities.
Malaffi
Malaffi is the region’s first Health Information Exchange platform, that safely and securely connects public and private healthcare providers in the Emirate of Abu Dhabi. Malaffi enables the meaningful, real-time exchange of important patient health information between the healthcare providers, creating a centralized database of unified patient records, improving healthcare quality and patient outcomes. Malaffi (Arabic for ‘my file’), is operated by Abu Dhabi Health Data Services – Sole Proprietorship LLC (ADHDS), established as Public Private Partnership (PPP) between the Department of Health – Abu Dhabi (DOH) and Injazat, a regional leader in digital transformation, cloud, and cyber security. As part of the DOH’s strategic priorities, Malaffi is a key component of the digital transformation of the healthcare system in Abu Dhabi. With universal, Emirate-wide participation of facilities and patients, every medical interaction a patient has, from a routine checkup, consultation or emergency treatment, to laboratory tests or radiology reports, is now collated in their personal file, with their medical history safely and securely stored and instantly accessible when needed. By providing instant access to the patient’s longitudinal medical file, Malaffi facilitates the making of better-informed and more efficient clinical decisions, enhances coordination and transition of care, reduces unnecessary duplication of tests and procedures, reduces the risk of medical error, and improve patient safety and experience. As a centralized database of robust population health information, Malaffi informs and drives the DOH’s public health initiatives for a healthier Abu Dhabi. In the future, using AI technology and machine learning, Malaffi will increasingly be used to reduce disease progression, promote improved health outcomes and, ultimately, prolong life.
Data Privacy Patient Healthcare Data Privacy Standard act as the general data protection regulation in the emirate to safeguard and protect the privacy of the patients and stakeholders in the healthcare sector.
IoMT
Internet Of Medical Things Security Standard As part of AAMEN program initiatives DoH seeks to strengthen the emirates healthcare sector cybersecurity, through partnering with the Abu Dhabi healthcare sector CERT team to mitigate the cyber risk proactively while creating a solid infrastructure and an ecosystem for information sharing, as well as facilitating and ensuring business continuity. Abu Dhabi Healthcare Computer Emergency Response Team – Healthcare CERT As part of AAMEN program initiatives Department of Health seeks to strengthen the emirate's healthcare sector cybersecurity, by establishing Abu Dhabi Healthcare CERT. The main goal of the Healthcare CERT, from a cybersecurity perspective, is to protect information, and the ability of critical infrastructures to continue to function. It typically monitors incidents at a sector level, identifies incidents that could affect critical infrastructures, warns critical stakeholders about computer security threats, and helps to build organizational CERTs in the public and private sectors.
Dubai (UAE) Healthcare Regulations
Dubai Telehealth Standard
Dubai Telehealth Standard The advancements in medical and communications technology has had a profound impact on the healthcare services globally. Telehealth offers the opportunity to improve the delivery and accessibility of healthcare services at low cost. It also provides the means for leveraging scarce resources and improving care and access for patients in remote areas. The appropriate application of telehealth technologies can enhance the provision of healthcare services by facilitating communication between physicians/ nurses/ allied health professionals and patients. Telehealth services include but are not limited to scheduling appointments, assessment, providing medical advice, treatment, therapy, laboratory testing, diagnostics, surgery, monitoring chronic conditions, counselling and prescribing and dispensing of medications. The DHA Standard was developed to improve the scope, effectiveness, efficiency, quality, and safety of Telehealth services in the Emirate of Dubai.
Telehealth is divided into six key areas:
- Teleconsultation;
- Telediagnosis;
- Telemonitoring (remote patient monitoring);
- Mhealth (Mobile Health);
- Telerobotics and robot-assisted services; and
- Telepharmacy.