Guideline

A guideline is a general rule, principle, or piece of advice that recommends or influences a course of action in specific situations, often to promote consistency, efficiency, or best practices.^[1] Unlike mandatory policies or regulations, guidelines are typically advisory and flexible, allowing adaptation to individual circumstances while providing a structured framework for decision-making.^[2] Guidelines serve critical roles across diverse domains, including healthcare, where clinical guidelines synthesize evidence-based recommendations to assist practitioners in patient management and improve outcomes.^[3] In public health and policy, organizations like the World Health Organization develop guidelines to inform clinical practice and formulate strategies for disease prevention and health promotion.^[4] Similarly, in professional and technical fields, such as engineering and information security, guidelines outline recommended configurations or procedures to mitigate risks and ensure operational reliability.^[5] The development of effective guidelines emphasizes attributes like clarity, evidence-based foundations, and applicability, enabling them to guide behaviors without rigid enforcement.^[3] By standardizing approaches, guidelines reduce variability in practices, foster accountability, and support informed choices in complex environments.^[6]

Definition and Characteristics

Definition

A guideline is a statement issued by an authoritative body that provides recommendations on how to approach a specific issue, problem, or task, typically grounded in evidence, expert consensus, or best practices.^[7] These recommendations aim to promote consistency, efficiency, and optimal outcomes without imposing strict obligations.^[2] Unlike laws, which are mandatory rules enacted by governmental authorities and enforceable through legal sanctions such as fines or penalties, guidelines are non-binding and advisory in nature.^[8] Similarly, guidelines differ from standards, which establish specific, often enforceable criteria for performance, quality, or compliance within an organization or industry, whereas guidelines allow for flexibility and adaptation to varying contexts.^[7] Core elements of a guideline generally encompass a clear rationale explaining the purpose and basis of the recommendations, an evidence base derived from systematic reviews or data analysis, and specification of the intended audience, such as practitioners, policymakers, or the public, to ensure targeted applicability.^[9]

Key Characteristics

Guidelines are distinguished by their flexibility, which permits adaptation to diverse contexts and individual circumstances without the imposition of strict mandates. This characteristic allows practitioners or organizations to tailor recommendations to specific needs, such as varying patient profiles in healthcare or operational differences in policy implementation, thereby enhancing practical utility.^[10] Unlike rigid policies or laws, guidelines promote discretionary application, fostering innovation and responsiveness while minimizing unintended consequences from overly prescriptive rules.^[11] A core feature of effective guidelines is their evidence-based foundation, typically derived from systematic reviews of research, expert consensus, or empirical data analysis to ensure recommendations are grounded in reliable knowledge. This approach contrasts with anecdotal or tradition-based directives, prioritizing interventions that have demonstrated efficacy through rigorous evaluation.^[12] For instance, in clinical settings, guidelines integrate high-quality evidence to balance benefits and risks, while in organizational contexts, they draw on data to support best practices.^[3] Guidelines generally hold non-binding status, meaning adherence is voluntary and encouraged through persuasion rather than legal compulsion, which supports broader acceptance and ethical alignment. This status distinguishes them from enforceable regulations, allowing for experimentation and feedback loops that refine future iterations without punitive measures.^[13] It encourages self-motivated compliance, particularly in professional fields where autonomy is valued, while still providing a benchmark for accountability.^[14] In terms of structure, guidelines are typically organized with explicit steps, accompanying rationales for each recommendation, and mechanisms for periodic updates to maintain relevance amid evolving evidence or contexts. This formatting—often including summaries, flowcharts, or graded strength indicators—facilitates comprehension and implementation by diverse audiences.^[15] Scheduled reviews ensure ongoing validity, addressing gaps in initial evidence or emerging developments, thereby sustaining their trustworthiness over time.^[3]

Historical Development

Origins

The concept of guidelines as tools for standardization traces its roots to ancient civilizations, where structured directives served to regulate behavior and ensure consistency in social, moral, and legal domains. In religious texts, early forms emerged as divine commandments providing prescriptive rules for communal conduct; for instance, the Ten Commandments in the Hebrew Bible, revealed to Moses around the 13th century BCE, outlined fundamental moral and ethical standards to guide Israelite society, emphasizing prohibitions against idolatry, murder, theft, and false witness.^[16] Similarly, in ancient Roman law, advisory opinions from jurists began to influence legal practice around the 3rd century BCE, following the codification of the Twelve Tables in 451–450 BCE, which standardized civil procedures and property rights to promote equity and predictability in disputes.^[17] During the medieval period in Europe, from the 12th to 15th centuries, craft guilds formalized guidelines to regulate artisanal production and maintain quality control, evolving from informal merchant associations into structured organizations that enforced uniform standards across trades like weaving, blacksmithing, and masonry. These guilds established rules on apprenticeship durations, material usage, and finished product specifications, with inspectors imposing fines or expulsion for substandard work to protect consumers and uphold professional reputation.^[18][19] Such measures not only standardized craftsmanship but also fostered economic stability by limiting competition and ensuring reliable output in burgeoning urban markets.^[20] The 19th century marked the formalization of guidelines within professional associations, particularly in medicine, as responses to inconsistent practices and public health challenges amid industrialization. The American Medical Association (AMA), founded in 1847, adopted its inaugural Code of Medical Ethics that year, which outlined principles for physician conduct, patient care, and professional interactions, aiming to elevate standards and counter quackery; this code, influenced by earlier British models, emphasized duties like confidentiality and competence, setting a precedent for systematic ethical guidelines in healthcare.^[21][22] This development reflected broader efforts in emerging professions to codify best practices for accountability and societal benefit.^[23]

Modern Evolution

The modern evolution of guidelines began in the 20th century with the rise of scientific management principles, which formalized structured approaches to workplace processes and influenced the development of operational guidelines across industries. Frederick Winslow Taylor's The Principles of Scientific Management, published in 1911, advocated for the systematic analysis of tasks to optimize efficiency, breaking down work into standardized steps that served as foundational guidelines for labor management and productivity enhancement.^[24] This Taylorist framework, emphasizing time-motion studies and worker training protocols, permeated manufacturing and administrative sectors, establishing guidelines as tools for rationalizing complex systems and reducing variability in performance.^[25] Post-World War II, international organizations accelerated this trend; the World Health Organization (WHO), established in 1948, began issuing global health guidelines to coordinate responses to diseases like malaria and tuberculosis, marking a shift toward standardized, evidence-informed international protocols.^[26][27] A pivotal milestone in the 1970s was the emergence of the evidence-based medicine (EBM) movement, which elevated guideline rigor by mandating systematic reviews of clinical research to inform recommendations. Pioneered by figures like Archie Cochrane, whose 1972 book Effectiveness and Efficiency: Random Reflections on Health Services critiqued the lack of randomized controlled trials in medical practice, EBM formalized processes for guideline creation, emphasizing hierarchies of evidence such as meta-analyses over anecdotal expertise.^[28] This era's advancements, including the establishment of the Cochrane Collaboration in 1993 as a direct outgrowth, transformed guidelines into dynamic, periodically updated documents grounded in empirical data, influencing fields beyond healthcare by promoting transparency and reproducibility.^[29] In the 21st century, digital technologies have reshaped guideline development through online collaboration and automation, particularly evident in the open-source software movement of the late 1990s onward. The Open Source Initiative, founded in 1998, standardized licenses and contribution guidelines that enabled global, decentralized teams to iteratively refine software protocols via platforms like GitHub, fostering community-driven updates and version control systems.^[30] This collaborative model extended to broader guideline ecosystems, where wikis and shared repositories allow real-time input from diverse stakeholders. More recently, artificial intelligence has facilitated guideline updates by automating evidence synthesis and gap analysis; for instance, AI tools now assist in scanning vast literature databases to recommend revisions, reducing development time from years to months while maintaining methodological integrity.^[31]

Types of Guidelines

Formal Guidelines

Formal guidelines are structured, authoritative documents issued by governments, international organizations, or recognized standards bodies, such as the International Organization for Standardization (ISO), to provide detailed recommendations on practices, procedures, or compliance requirements. These guidelines typically undergo formal approval processes that lend them credibility and, in many cases, legal backing when integrated into regulatory frameworks or used as criteria for certification programs, ensuring that adherence demonstrates conformity to established norms.^[32][33] The development of formal guidelines emphasizes rigor, beginning with the identification of needs by stakeholders and proceeding through drafting by expert technical committees, multi-stakeholder consultations for feedback, and consensus-building via structured voting mechanisms. This process, which often spans about three years for ISO standards, incorporates iterative reviews to refine content and address diverse inputs from industry, consumers, governments, and other experts. Periodic revisions are mandated, with ISO standards systematically reviewed every five years to confirm, amend, or withdraw them based on technological advancements and practical applicability.^[32][34] Key examples of formal guidelines include the ISO 9000 family, which establishes criteria for quality management systems and enables third-party certification, and the U.S. Food and Drug Administration's (FDA) regulatory guidances on drug development and approval processes, which outline steps for ensuring product safety, efficacy, and manufacturing consistency. Unlike informal guidelines, formal ones often carry implications for legal compliance or certification in regulated environments.^[35]

Informal Guidelines

Informal guidelines refer to unofficial, community-driven recommendations that emerge organically from peer groups, online communities, or longstanding traditions, guiding behavior through social consensus rather than enforced authority.^[36] These guidelines lack formal institutional backing, allowing them to evolve rapidly in response to collective experiences and feedback within the group. For instance, in online communities, netiquette represents a set of informal rules for respectful digital interactions, such as using proper grammar, avoiding flame wars, and respecting privacy in emails.^[37] A key feature of informal guidelines is their flexibility, enabling quick adaptation to new contexts without bureaucratic processes, though this can lead to inconsistencies in application across subgroups.^[38] Their accessibility promotes widespread participation, as they rely on shared values rather than official documentation, fostering a sense of ownership among community members. However, the absence of standardization may result in varying interpretations, potentially causing confusion or conflicts.^[39] Common contexts for informal guidelines include social media etiquette, where rules like keeping messages brief and empathetic help maintain positive online discourse without platform mandates.^[37] In open-source software development, coding conventions and contribution etiquette—such as being polite in discussions, focusing on meaningful fixes like documentation errors, and respecting project channels—emerge from volunteer communities to enhance collaboration.^[40] These examples illustrate how informal guidelines support cohesive group dynamics, differing from formal guidelines by prioritizing voluntary adherence over obligation.

Creation and Implementation

Development Process

The development of guidelines follows a rigorous, systematic methodology to ensure they are evidence-informed, transparent, and applicable, though processes vary by field. In healthcare and evidence-based domains, this process begins with a needs assessment, where potential topics are identified based on identified gaps in knowledge, practice variations, or emerging health priorities, followed by scoping to define the guideline's objectives, target audience, and key questions.^[41] The scoping stage involves collaboration among relevant experts to outline the boundaries and feasibility of the guideline, preventing overly broad or unfocused efforts.^[42] Evidence gathering constitutes a core stage, primarily through conducting or commissioning systematic reviews to retrieve, appraise, and synthesize relevant data from clinical trials, observational studies, and other sources. In clinical fields, quality appraisal of this evidence often employs the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system, which categorizes the certainty of evidence as high, moderate, low, or very low based on factors like risk of bias, inconsistency, and precision.^[43] In technical fields like engineering, evidence may include testing data and expert consensus rather than solely systematic reviews. This stage ensures that recommendations are grounded in the best available evidence rather than opinion alone.^[41] Drafting the guideline is then undertaken by a multidisciplinary panel of experts, who formulate recommendations by integrating the synthesized evidence with considerations of benefits, harms, values, and resource implications. Tools such as evidence-to-decision frameworks within GRADE guide this integration in health contexts, while consensus-building methods are used elsewhere to produce clear, actionable statements.^[43] Stakeholder feedback follows, incorporating input from external experts, patients, and organizations through iterative rounds to refine the draft; the Delphi method, involving anonymous questionnaires and controlled feedback across multiple rounds, is commonly used to build consensus on contentious issues.^[44] This method minimizes dominance by individuals and fosters agreement among diverse viewpoints.^[44] The process culminates in final approval by an oversight body, such as a guidelines review committee, which verifies methodological rigor and alignment with field-specific standards, like those in the WHO Handbook for Guideline Development in health or the ISO/IEC Directives for international standards.^[41][32] Pilots or field tests may be conducted during or after drafting to assess practicality before approval. Overall, guideline development typically spans 1-3 years, depending on complexity and resources, allowing sufficient time for thorough evidence synthesis and iteration.^[45] Stakeholders, including clinicians and policymakers, are engaged throughout to ensure relevance, though their roles in adoption occur post-development.^[41]

Adoption and Enforcement

Adoption of guidelines typically follows their development process and involves targeted strategies to integrate them into organizational practices. Key tactics include comprehensive training programs designed to build awareness and skills among stakeholders, ensuring that personnel understand the rationale and application of the guidelines. For instance, educational workshops and ongoing professional development sessions have been shown to enhance uptake by addressing knowledge gaps and fostering buy-in. Integration into existing policies is another critical approach, where guidelines are embedded within operational frameworks, such as updating procedural manuals or linking them to performance evaluations, to make compliance a seamless part of daily workflows. Incentives for adherence, such as certification rewards or recognition programs, further encourage adoption; organizations often offer credentials like ISO certifications or internal accolades that signal commitment to standards, motivating teams through tangible benefits like career advancement or funding access.^[46][47] Enforcement mechanisms for guidelines emphasize monitoring and accountability rather than punitive measures, given their often voluntary nature. Common methods include regular audits to assess compliance levels, where independent reviewers evaluate adherence through document reviews and on-site observations, providing feedback for improvements. Voluntary reporting systems allow organizations to self-assess and disclose progress, promoting transparency without coercion and enabling peer benchmarking. Soft penalties, such as reputational damage from public non-compliance reports or loss of professional standing, serve as deterrents, while legal sanctions are rare and typically reserved for cases where guidelines intersect with binding regulations. These approaches prioritize sustained behavior change over strict imposition, with effectiveness tied to clear metrics and periodic reviews.^[48][49][50] Despite these strategies, challenges in adoption and enforcement persist, particularly resistance stemming from resource constraints like limited funding, time, or personnel. Organizations facing such barriers often encounter pushback from staff accustomed to prior practices, leading to inconsistent implementation. To mitigate this, phased rollouts are recommended, starting with pilot programs in select departments to test feasibility, gather feedback, and scale gradually while allocating resources incrementally. This method has proven effective in overcoming inertia by demonstrating early successes and adjusting for local needs, ultimately improving long-term adherence rates.^[51][52][53]

Applications Across Fields

In Healthcare

In healthcare, guidelines play a pivotal role in standardizing clinical practices to ensure consistent, evidence-based care across diverse patient populations. Clinical practice guidelines (CPGs) are systematically developed statements that include recommendations intended to optimize patient care, informed by systematic reviews of evidence and expert consensus.^[54] These guidelines address diagnostics, therapies, and management strategies, aiming to reduce unwarranted variations in treatment that can lead to suboptimal outcomes. For instance, the National Institute for Health and Care Excellence (NICE) in the United Kingdom produces guidelines for specific treatments, such as recommending cognitive behavioral therapy and selective serotonin reuptake inhibitors as first-line interventions for moderate to severe depression in adults.^[55] Similarly, NICE guidelines for type 2 diabetes management (NG28, as of 2022 with draft update August 2025) advocate metformin as initial pharmacotherapy unless contraindicated, promoting uniform approaches to glycemic control.^[56][57] By providing clear protocols, these tools help clinicians make informed decisions, particularly in complex cases involving comorbidities. The impact of adhering to healthcare guidelines is well-documented, with empirical evidence demonstrating enhancements in patient outcomes, including reduced mortality and improved quality of life. A review of studies highlights that guideline-concordant care lowers hospitalization risks in chronic heart failure by optimizing therapies like beta-blockers and ACE inhibitors.^[58] In oncology, adherence to breast cancer guidelines has been associated with higher survival rates, with one analysis showing up to 20-30% relative improvement in outcomes for patients receiving guideline-recommended adjuvant therapies compared to non-adherent cases.^[59] For infectious diseases, such as ventilator-associated pneumonia, guideline-directed antibiotic use has led to superior clinical resolutions and cost savings, underscoring the role of guidelines in diagnostics and therapies.^[58] Overall, meta-analyses indicate that implementation strategies for CPGs yield moderate to large effects on clinical processes and modest effects on patient outcomes.^[60] Since the 2010s, healthcare guidelines have evolved toward personalized medicine, increasingly incorporating genomic data to tailor interventions to individual genetic profiles. This shift reflects advances in pharmacogenomics, where guidelines now recommend genetic testing to guide drug selection and dosing, reducing adverse reactions and enhancing efficacy.^[61] For example, the Clinical Pharmacogenetics Implementation Consortium (CPIC) has issued guidelines since 2011 for drugs like warfarin and clopidogrel, advising adjustments based on CYP2C19 and VKORC1 variants to prevent bleeding or inefficacy risks. This genomic integration marks a departure from one-size-fits-all approaches, enabling precision in areas like oncology and cardiology, though challenges remain in equitable access and evidence synthesis for rare variants.^[62]

In Policy and Regulation

Guidelines in policy and regulation serve critical roles in informing legislation and shaping internal organizational policies. The United States Environmental Protection Agency (EPA) issues guidance documents that clarify statutory requirements and assist in the practical implementation of environmental laws, such as those under the Clean Air Act and Clean Water Act, thereby translating broad legislative mandates into actionable standards for regulated entities.^[63] In organizational settings, corporate ethics guidelines function as internal policies that outline principles of honesty, integrity, and compliance, guiding employee behavior to align with legal obligations while promoting broader social responsibilities like sustainability and stakeholder welfare.^[64] These guidelines often bridge the gap between formal laws and operational practices by providing detailed frameworks for compliance and ethical conduct. For example, the General Data Protection Regulation (GDPR), effective since May 25, 2018, establishes comprehensive guidelines on data privacy principles—such as lawfulness, minimization, and accountability—that organizations must integrate into their daily processes, influencing global standards for handling personal data and enabling enforcement through fines up to 4% of annual global turnover.^[65] Globally, the United Nations advances harmonization of international policy guidelines to foster consistency across jurisdictions and reduce redundancies in implementation. A key initiative is the Harmonized Guidelines on Reporting under International Human Rights Treaties, introduced in 2006, which standardizes state reporting to UN treaty bodies through a Common Core Document that details national laws, policies, and human rights infrastructure, complemented by treaty-specific reports for targeted analysis.^[66] This approach enhances the efficiency of monitoring human rights obligations and facilitates coordinated international efforts.^[67]

Notable Examples and Lists

Prominent Guidelines

Prominent guidelines are selected based on their high impact, widespread recognition, and adoption across global institutions, often serving as benchmarks for professional practice, safety, and policy implementation. These examples span diverse fields, demonstrating how guidelines establish standards that influence outcomes such as reduced risks, improved compliance, and sustainable development. The World Health Organization's Guidelines on Hand Hygiene in Health Care (2009) originated from a collaborative effort involving over 100 international experts to address healthcare-associated infections (HCAIs), which affect millions annually. Key provisions include the "Five Moments for Hand Hygiene"—before touching a patient, before clean/aseptic procedures, after body fluid exposure risk, after touching a patient, and after touching patient surroundings—along with recommendations on alcohol-based hand rubs, soap-and-water techniques, and multimodal improvement strategies. Implementation has led to up to 50% reduction in avoidable HCAIs and significant economic savings through shorter hospital stays and lower treatment costs, with global adoption in over 190 countries enhancing infection control during events like the COVID-19 pandemic.^[68] The American Psychological Association's Ethical Principles of Psychologists and Code of Conduct, first adopted in 1953 and substantially revised in 2002 with amendments in 2017, emerged as a response to evolving professional needs in psychology, drawing from ethical philosophy and legal standards. Its core elements comprise five aspirational principles—beneficence and nonmaleficence, fidelity and responsibility, integrity, justice, and respect for people's rights and dignity—paired with ten enforceable standards addressing competence, human relations, privacy, assessment, therapy, research, and organizational demands. This code profoundly shapes ethical decision-making, influencing licensing boards, academic training, and disciplinary actions, while promoting public trust and reducing ethical violations in clinical, research, and consulting contexts worldwide.^[69] In engineering, the American Society of Mechanical Engineers' Boiler and Pressure Vessel Code (BPVC), initiated in 1911 following fatal boiler explosions and first published in 1914–1915, was developed to standardize safe design and operation amid industrial growth. Key provisions cover materials, fabrication, inspection, testing, and certification for power boilers, pressure vessels, and nuclear components across multiple sections, emphasizing risk-based engineering to prevent failures. Adopted into law in most U.S. states and over 100 countries, it has drastically reduced accidents—such as boiler ruptures that previously caused hundreds of deaths annually—saving lives, enabling safer infrastructure, and supporting industries like energy and manufacturing with over 92,000 copies in use globally.^[70] For international health policy, the World Health Organization's International Health Regulations (2005), revised from the 1969 version and adopted by the World Health Assembly, provide a binding framework for 196 countries to prevent and respond to public health risks of international concern. Central elements include mandatory notification of potential emergencies within 24 hours, core capacities for surveillance and response (e.g., detection labs and points of entry screening), and collaborative mechanisms like the Emergency Committee for coordinated action. Ratified nearly universally, it has strengthened global preparedness, facilitating rapid responses to outbreaks like Ebola and COVID-19, while reducing cross-border spread and enhancing equity in health security through annual progress reporting. In environmental policy, the International Finance Corporation's Performance Standards on Environmental and Social Sustainability (2006, revised 2012), part of the World Bank Group's framework, were created to guide private-sector investments in developing countries toward responsible practices. The eight standards outline requirements for assessing and managing risks, including environmental impact identification, labor rights, pollution prevention, community health, land acquisition, biodiversity conservation, indigenous peoples' rights, and cultural heritage protection, with emphasis on stakeholder engagement and grievance mechanisms. Applied to thousands of projects financing over $100 billion annually, they have mitigated adverse effects—such as reducing greenhouse gas emissions and resolving community conflicts—while promoting sustainable development and influencing national regulations in emerging markets.^[71]

Healthcare

Guidelines in healthcare provide evidence-based recommendations for clinical practice, public health, and patient management, issued by international and national organizations. These documents are regularly updated to reflect new research and health priorities, with many revisions occurring post-2020 in response to global challenges like pandemics and chronic disease management. The following table lists representative examples from key issuing bodies, focusing on updates or publications after 2020 where available.

Technology

In the technology domain, guidelines and standards focus on interoperability, safety, and ethical implementation of systems, primarily developed by engineering societies. Post-2020 updates emphasize emerging technologies like wireless communications and bioinformatics. The list below highlights key IEEE standards approved or revised after 2020.

• IEEE 2791-2020: Standard for Bioinformatics Computations and Analyses Generated by High-Throughput Sequencing (HTS) to Support Clinical Decisions in Precision Medicine ^[85]
• IEEE 802.11be (Extreme High Throughput): Amendment for next-generation Wi-Fi standards, approved 2024 ^[86]
• IEEE 802.11bn (Ultra High Reliability): Amendment for industrial IoT applications, under development post-2020 ^[86]
• IEEE 1900.6-2020: Standard for Spectrum Sensing Interfaces and Data Structures for Dynamic Spectrum Access ^[87]
• IEEE 1277-2020: Standard General Requirements and Test Code for Dry-Type and Oil-Immersed Smoothing Reactors ^[87]
• IEEE P802.3df: Higher Speed Ethernet Amendment for 800 Gb/s, initiated post-2020 ^[88]
• IEEE IRDS 2020 Edition: International Roadmap for Devices and Systems, covering beyond-CMOS technologies ^[89]
• IEEE 802.11bt (Wired Profile for Wireless Access): Amendment for power delivery over Ethernet, 2020 ^[86]
• IEEE 802.11br (Enhanced Broadcast Service): Amendment for vehicular communications, post-2020 ^[86]
• IEEE 802.11bq (Enhanced Open Roaming): Amendment for seamless Wi-Fi transitions, 2023 ^[86]

Environment

Environmental guidelines address climate assessment, emissions reporting, and sustainable practices, often from intergovernmental panels. Post-2020 refinements incorporate updated data on global warming and biodiversity. Representative examples from IPCC and related bodies include:

• 2019 Refinement to the 2006 IPCC Guidelines for National Greenhouse Gas Inventories: Updates methodologies for emissions accounting ^[90]
• 2006 IPCC Guidelines for National Greenhouse Gas Inventories (Volume 4: Agriculture, Forestry and Other Land Use): Core framework with post-2020 applications
• Good Practice Guidance and Uncertainty Management in National Greenhouse Gas Inventories: IPCC 2000, refined post-2020 for inventory accuracy ^[91]
• IPCC Data Distribution Centre Technical Guidelines: Best practices for accessing climate data, updated 2021 ^[92]
• 2023 IPCC Synthesis Report: Guidelines on climate impacts and adaptation options ^[93]
• UNEP/MAP Technical Guidelines on Marine Litter: Prevention and management protocols, revised 2022 ^[94]
• IPCC 2021 Global Warming Potential Values: For GHG accounting, AR6 basis ^[95]
• 2019 Refinement Volume 2: Energy (IPCC): Sector-specific emissions guidelines ^[90]
• Ongoing development of a global plastics treaty under UNEP, with implementation guidelines anticipated ^[96]
• IPCC Methodology Report on Short-lived Climate Forcers: 2021 guidance on non-CO2 gases ^[93]

Policy and Regulation

Policy and regulation guidelines establish frameworks for governance, compliance, and risk management across sectors. Issuing bodies include federal agencies and international organizations, with post-2020 emphases on digital and health regulations. Examples include:

• FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: 2020, updated 2023 ^[97]
• OSHA Heat Injury and Illness Prevention Proposed Rule: Guidelines for workplace safety, 2024 ^[98]
• CMS Guide to Federal Laws, Regulations, and Policies: Information security in healthcare, ongoing post-2020 ^[99]
• EU Regulation (EU) 2024/1689 on Harmonised Rules for Artificial Intelligence: AI governance framework
• HHS Regulations Toolkit: Federal rulemaking processes, updated 2024 ^[100]
• Clean Air Act Implementation Guidelines: EPA standards for pollutants, refined post-2020
• Family Smoking Prevention and Tobacco Control Act Guidelines: FDA enforcement, 2022 updates ^[101]
• Occupational Safety and Health Act General Industry Standards: OSHA, ongoing revisions ^[98]
• Financial Regulations under Dodd-Frank Act: SEC guidelines, post-2020 amendments
• HIPAA Privacy Rule: HHS guidelines for health data protection, 2024 modifications

AI Ethics

AI ethics guidelines promote responsible development and deployment, addressing bias, transparency, and societal impact. Post-2020, organizations have issued frameworks aligned with regulations like the EU AI Act. The following lists key examples:

• Recommendation on the Ethics of Artificial Intelligence: UNESCO, 2021, first global standard ^[102]
• Ethics Guidelines for Trustworthy AI: European Commission High-Level Expert Group, 2019, applied post-2020
• AI Ethics and Governance Guidance for Large Multi-Modal Models: WHO, 2024 ^[103]
• Artificial Intelligence Ethics Framework for the Intelligence Community: U.S. Office of the Director of National Intelligence, 2020 ^[104]
• IEEE Ethically Aligned Design for Autonomous and Intelligent Systems: IEEE, 2020 edition
• Guidelines on AI Systems Under the EU AI Act: European Commission, draft 2025 ^[105]
• Global AI Ethics and Governance Observatory: UNESCO, ongoing post-2021
• Business Council for Ethics of AI: UNESCO initiative, 2022 ^[102]
• AI Ethics Guidelines for Developers and Users: Various academic consortia, 2021 compilation