case study research in information systems

Guidelines for Conducting Positivist Case Study Research in Information Systems

• Graeme Shanks

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Principles for conducting critical realist case study research in information systems

School of Business Administration, University of Dayton, Dayton, OH

Southern Illinois University Edwardsville, Edwardsville, IL

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Critical realism is emerging as a viable philosophical paradigm for conducting social science research, and has been proposed as an alternative to the more prevalent paradigms of positivism and interpretivism. Few papers, however, have offered clear guidance for applying this philosophy to actual research methodologies. Under critical realism, a causal explanation for a given phenomenon is inferred by explicitly identifying the means by which structural entities and contextual conditions interact to generate a given set of events. Consistent with this view of causality, we propose a set of methodological principles for conducting and evaluating critical realism-based explanatory case study research within the information systems field. The principles are derived directly from the ontological and epistemological assumptions of critical realism. We demonstrate the utility of each of the principles through examples drawn from existing critical realist case studies. The article concludes by discussing the implications of critical realism based research for IS research and practice.

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• Published: 1 September 2012

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• case study research
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• DOI: 10.1016/B978-0-08-102220-7.00007-8
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Case study research in information systems

• G. Shanks , Nargiza Bekmamedova
• Published 2018
• Computer Science

10 Citations

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The state of AI in early 2024: Gen AI adoption spikes and starts to generate value

If 2023 was the year the world discovered generative AI (gen AI) , 2024 is the year organizations truly began using—and deriving business value from—this new technology. In the latest McKinsey Global Survey  on AI, 65 percent of respondents report that their organizations are regularly using gen AI, nearly double the percentage from our previous survey just ten months ago. Respondents’ expectations for gen AI’s impact remain as high as they were last year , with three-quarters predicting that gen AI will lead to significant or disruptive change in their industries in the years ahead.

About the authors

This article is a collaborative effort by Alex Singla , Alexander Sukharevsky , Lareina Yee , and Michael Chui , with Bryce Hall , representing views from QuantumBlack, AI by McKinsey, and McKinsey Digital.

Organizations are already seeing material benefits from gen AI use, reporting both cost decreases and revenue jumps in the business units deploying the technology. The survey also provides insights into the kinds of risks presented by gen AI—most notably, inaccuracy—as well as the emerging practices of top performers to mitigate those challenges and capture value.

AI adoption surges

Interest in generative AI has also brightened the spotlight on a broader set of AI capabilities. For the past six years, AI adoption by respondents’ organizations has hovered at about 50 percent. This year, the survey finds that adoption has jumped to 72 percent (Exhibit 1). And the interest is truly global in scope. Our 2023 survey found that AI adoption did not reach 66 percent in any region; however, this year more than two-thirds of respondents in nearly every region say their organizations are using AI. 1 Organizations based in Central and South America are the exception, with 58 percent of respondents working for organizations based in Central and South America reporting AI adoption. Looking by industry, the biggest increase in adoption can be found in professional services. 2 Includes respondents working for organizations focused on human resources, legal services, management consulting, market research, R&D, tax preparation, and training.

Also, responses suggest that companies are now using AI in more parts of the business. Half of respondents say their organizations have adopted AI in two or more business functions, up from less than a third of respondents in 2023 (Exhibit 2).

Gen AI adoption is most common in the functions where it can create the most value

Most respondents now report that their organizations—and they as individuals—are using gen AI. Sixty-five percent of respondents say their organizations are regularly using gen AI in at least one business function, up from one-third last year. The average organization using gen AI is doing so in two functions, most often in marketing and sales and in product and service development—two functions in which previous research  determined that gen AI adoption could generate the most value 3 “ The economic potential of generative AI: The next productivity frontier ,” McKinsey, June 14, 2023. —as well as in IT (Exhibit 3). The biggest increase from 2023 is found in marketing and sales, where reported adoption has more than doubled. Yet across functions, only two use cases, both within marketing and sales, are reported by 15 percent or more of respondents.

Gen AI also is weaving its way into respondents’ personal lives. Compared with 2023, respondents are much more likely to be using gen AI at work and even more likely to be using gen AI both at work and in their personal lives (Exhibit 4). The survey finds upticks in gen AI use across all regions, with the largest increases in Asia–Pacific and Greater China. Respondents at the highest seniority levels, meanwhile, show larger jumps in the use of gen Al tools for work and outside of work compared with their midlevel-management peers. Looking at specific industries, respondents working in energy and materials and in professional services report the largest increase in gen AI use.

Investments in gen AI and analytical AI are beginning to create value

The latest survey also shows how different industries are budgeting for gen AI. Responses suggest that, in many industries, organizations are about equally as likely to be investing more than 5 percent of their digital budgets in gen AI as they are in nongenerative, analytical-AI solutions (Exhibit 5). Yet in most industries, larger shares of respondents report that their organizations spend more than 20 percent on analytical AI than on gen AI. Looking ahead, most respondents—67 percent—expect their organizations to invest more in AI over the next three years.

Where are those investments paying off? For the first time, our latest survey explored the value created by gen AI use by business function. The function in which the largest share of respondents report seeing cost decreases is human resources. Respondents most commonly report meaningful revenue increases (of more than 5 percent) in supply chain and inventory management (Exhibit 6). For analytical AI, respondents most often report seeing cost benefits in service operations—in line with what we found last year —as well as meaningful revenue increases from AI use in marketing and sales.

Inaccuracy: The most recognized and experienced risk of gen AI use

As businesses begin to see the benefits of gen AI, they’re also recognizing the diverse risks associated with the technology. These can range from data management risks such as data privacy, bias, or intellectual property (IP) infringement to model management risks, which tend to focus on inaccurate output or lack of explainability. A third big risk category is security and incorrect use.

Respondents to the latest survey are more likely than they were last year to say their organizations consider inaccuracy and IP infringement to be relevant to their use of gen AI, and about half continue to view cybersecurity as a risk (Exhibit 7).

Conversely, respondents are less likely than they were last year to say their organizations consider workforce and labor displacement to be relevant risks and are not increasing efforts to mitigate them.

In fact, inaccuracy— which can affect use cases across the gen AI value chain , ranging from customer journeys and summarization to coding and creative content—is the only risk that respondents are significantly more likely than last year to say their organizations are actively working to mitigate.

Some organizations have already experienced negative consequences from the use of gen AI, with 44 percent of respondents saying their organizations have experienced at least one consequence (Exhibit 8). Respondents most often report inaccuracy as a risk that has affected their organizations, followed by cybersecurity and explainability.

Our previous research has found that there are several elements of governance that can help in scaling gen AI use responsibly, yet few respondents report having these risk-related practices in place. 4 “ Implementing generative AI with speed and safety ,” McKinsey Quarterly , March 13, 2024. For example, just 18 percent say their organizations have an enterprise-wide council or board with the authority to make decisions involving responsible AI governance, and only one-third say gen AI risk awareness and risk mitigation controls are required skill sets for technical talent.

Bringing gen AI capabilities to bear

The latest survey also sought to understand how, and how quickly, organizations are deploying these new gen AI tools. We have found three archetypes for implementing gen AI solutions : takers use off-the-shelf, publicly available solutions; shapers customize those tools with proprietary data and systems; and makers develop their own foundation models from scratch. 5 “ Technology’s generational moment with generative AI: A CIO and CTO guide ,” McKinsey, July 11, 2023. Across most industries, the survey results suggest that organizations are finding off-the-shelf offerings applicable to their business needs—though many are pursuing opportunities to customize models or even develop their own (Exhibit 9). About half of reported gen AI uses within respondents’ business functions are utilizing off-the-shelf, publicly available models or tools, with little or no customization. Respondents in energy and materials, technology, and media and telecommunications are more likely to report significant customization or tuning of publicly available models or developing their own proprietary models to address specific business needs.

Respondents most often report that their organizations required one to four months from the start of a project to put gen AI into production, though the time it takes varies by business function (Exhibit 10). It also depends upon the approach for acquiring those capabilities. Not surprisingly, reported uses of highly customized or proprietary models are 1.5 times more likely than off-the-shelf, publicly available models to take five months or more to implement.

Gen AI high performers are excelling despite facing challenges

Gen AI is a new technology, and organizations are still early in the journey of pursuing its opportunities and scaling it across functions. So it’s little surprise that only a small subset of respondents (46 out of 876) report that a meaningful share of their organizations’ EBIT can be attributed to their deployment of gen AI. Still, these gen AI leaders are worth examining closely. These, after all, are the early movers, who already attribute more than 10 percent of their organizations’ EBIT to their use of gen AI. Forty-two percent of these high performers say more than 20 percent of their EBIT is attributable to their use of nongenerative, analytical AI, and they span industries and regions—though most are at organizations with less than $1 billion in annual revenue. The AI-related practices at these organizations can offer guidance to those looking to create value from gen AI adoption at their own organizations.

To start, gen AI high performers are using gen AI in more business functions—an average of three functions, while others average two. They, like other organizations, are most likely to use gen AI in marketing and sales and product or service development, but they’re much more likely than others to use gen AI solutions in risk, legal, and compliance; in strategy and corporate finance; and in supply chain and inventory management. They’re more than three times as likely as others to be using gen AI in activities ranging from processing of accounting documents and risk assessment to R&D testing and pricing and promotions. While, overall, about half of reported gen AI applications within business functions are utilizing publicly available models or tools, gen AI high performers are less likely to use those off-the-shelf options than to either implement significantly customized versions of those tools or to develop their own proprietary foundation models.

What else are these high performers doing differently? For one thing, they are paying more attention to gen-AI-related risks. Perhaps because they are further along on their journeys, they are more likely than others to say their organizations have experienced every negative consequence from gen AI we asked about, from cybersecurity and personal privacy to explainability and IP infringement. Given that, they are more likely than others to report that their organizations consider those risks, as well as regulatory compliance, environmental impacts, and political stability, to be relevant to their gen AI use, and they say they take steps to mitigate more risks than others do.

Gen AI high performers are also much more likely to say their organizations follow a set of risk-related best practices (Exhibit 11). For example, they are nearly twice as likely as others to involve the legal function and embed risk reviews early on in the development of gen AI solutions—that is, to “ shift left .” They’re also much more likely than others to employ a wide range of other best practices, from strategy-related practices to those related to scaling.

In addition to experiencing the risks of gen AI adoption, high performers have encountered other challenges that can serve as warnings to others (Exhibit 12). Seventy percent say they have experienced difficulties with data, including defining processes for data governance, developing the ability to quickly integrate data into AI models, and an insufficient amount of training data, highlighting the essential role that data play in capturing value. High performers are also more likely than others to report experiencing challenges with their operating models, such as implementing agile ways of working and effective sprint performance management.

About the research

The online survey was in the field from February 22 to March 5, 2024, and garnered responses from 1,363 participants representing the full range of regions, industries, company sizes, functional specialties, and tenures. Of those respondents, 981 said their organizations had adopted AI in at least one business function, and 878 said their organizations were regularly using gen AI in at least one function. To adjust for differences in response rates, the data are weighted by the contribution of each respondent’s nation to global GDP.

Alex Singla and Alexander Sukharevsky  are global coleaders of QuantumBlack, AI by McKinsey, and senior partners in McKinsey’s Chicago and London offices, respectively; Lareina Yee  is a senior partner in the Bay Area office, where Michael Chui , a McKinsey Global Institute partner, is a partner; and Bryce Hall  is an associate partner in the Washington, DC, office.

They wish to thank Kaitlin Noe, Larry Kanter, Mallika Jhamb, and Shinjini Srivastava for their contributions to this work.

This article was edited by Heather Hanselman, a senior editor in McKinsey’s Atlanta office.

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• As Ozempic’s Popularity Soars, Here’s What to Know About Semaglutide and Weight Loss JAMA Medical News & Perspectives May 16, 2023 This Medical News article discusses chronic weight management with semaglutide, sold under the brand names Ozempic and Wegovy. Melissa Suran, PhD, MSJ
• Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists JAMA Special Communication August 15, 2023 This Special Communication used data from the US Food and Drug Administration to analyze how manufacturers of brand-name glucagon-like peptide 1 (GLP-1) receptor agonists have used patent and regulatory systems to extend periods of market exclusivity. Rasha Alhiary, PharmD; Aaron S. Kesselheim, MD, JD, MPH; Sarah Gabriele, LLM, MBE; Reed F. Beall, PhD; S. Sean Tu, JD, PhD; William B. Feldman, MD, DPhil, MPH
• What to Know About Wegovy’s Rare but Serious Adverse Effects JAMA Medical News & Perspectives December 12, 2023 This Medical News article discusses Wegovy, Ozempic, and other GLP-1 receptor agonists used for weight management and type 2 diabetes. Kate Ruder, MSJ
• GLP-1 Receptor Agonists and Gastrointestinal Adverse Events—Reply JAMA Comment & Response March 12, 2024 Ramin Rezaeianzadeh, BSc; Mohit Sodhi, MSc; Mahyar Etminan, PharmD, MSc
• GLP-1 Receptor Agonists and Gastrointestinal Adverse Events JAMA Comment & Response March 12, 2024 Karine Suissa, PhD; Sara J. Cromer, MD; Elisabetta Patorno, MD, DrPH
• GLP-1 Receptor Agonist Use and Risk of Postoperative Complications JAMA Research Letter May 21, 2024 This cohort study evaluates the risk of postoperative respiratory complications among patients with diabetes undergoing surgery who had vs those who had not a prescription fill for glucagon-like peptide 1 receptor agonists. Anjali A. Dixit, MD, MPH; Brian T. Bateman, MD, MS; Mary T. Hawn, MD, MPH; Michelle C. Odden, PhD; Eric C. Sun, MD, PhD
• Glucagon-Like Peptide-1 Receptor Agonist Use and Risk of Gallbladder and Biliary Diseases JAMA Internal Medicine Original Investigation May 1, 2022 This systematic review and meta-analysis of 76 randomized clinical trials examines the effects of glucagon-like peptide-1 receptor agonist use on the risk of gallbladder and biliary diseases. Liyun He, MM; Jialu Wang, MM; Fan Ping, MD; Na Yang, MM; Jingyue Huang, MM; Yuxiu Li, MD; Lingling Xu, MD; Wei Li, MD; Huabing Zhang, MD
• Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists JAMA Internal Medicine Research Letter October 1, 2022 This case series identifies cases reported in the US Food and Drug Administration Adverse Event Reporting System of acute cholecystitis associated with use of glucagon-like peptide-1 receptor agonists that did not have gallbladder disease warnings in their labeling. Daniel Woronow, MD; Christine Chamberlain, PharmD; Ali Niak, MD; Mark Avigan, MDCM; Monika Houstoun, PharmD, MPH; Cindy Kortepeter, PharmD

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Sodhi M , Rezaeianzadeh R , Kezouh A , Etminan M. Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss. JAMA. 2023;330(18):1795–1797. doi:10.1001/jama.2023.19574

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Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss

• 1 Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
• 2 StatExpert Ltd, Laval, Quebec, Canada
• 3 Department of Ophthalmology and Visual Sciences and Medicine, University of British Columbia, Vancouver, Canada
• Medical News & Perspectives As Ozempic’s Popularity Soars, Here’s What to Know About Semaglutide and Weight Loss Melissa Suran, PhD, MSJ JAMA
• Special Communication Patents and Regulatory Exclusivities on GLP-1 Receptor Agonists Rasha Alhiary, PharmD; Aaron S. Kesselheim, MD, JD, MPH; Sarah Gabriele, LLM, MBE; Reed F. Beall, PhD; S. Sean Tu, JD, PhD; William B. Feldman, MD, DPhil, MPH JAMA
• Medical News & Perspectives What to Know About Wegovy’s Rare but Serious Adverse Effects Kate Ruder, MSJ JAMA
• Comment & Response GLP-1 Receptor Agonists and Gastrointestinal Adverse Events—Reply Ramin Rezaeianzadeh, BSc; Mohit Sodhi, MSc; Mahyar Etminan, PharmD, MSc JAMA
• Comment & Response GLP-1 Receptor Agonists and Gastrointestinal Adverse Events Karine Suissa, PhD; Sara J. Cromer, MD; Elisabetta Patorno, MD, DrPH JAMA
• Research Letter GLP-1 Receptor Agonist Use and Risk of Postoperative Complications Anjali A. Dixit, MD, MPH; Brian T. Bateman, MD, MS; Mary T. Hawn, MD, MPH; Michelle C. Odden, PhD; Eric C. Sun, MD, PhD JAMA
• Original Investigation Glucagon-Like Peptide-1 Receptor Agonist Use and Risk of Gallbladder and Biliary Diseases Liyun He, MM; Jialu Wang, MM; Fan Ping, MD; Na Yang, MM; Jingyue Huang, MM; Yuxiu Li, MD; Lingling Xu, MD; Wei Li, MD; Huabing Zhang, MD JAMA Internal Medicine
• Research Letter Cholecystitis Associated With the Use of Glucagon-Like Peptide-1 Receptor Agonists Daniel Woronow, MD; Christine Chamberlain, PharmD; Ali Niak, MD; Mark Avigan, MDCM; Monika Houstoun, PharmD, MPH; Cindy Kortepeter, PharmD JAMA Internal Medicine

Glucagon-like peptide 1 (GLP-1) agonists are medications approved for treatment of diabetes that recently have also been used off label for weight loss. 1 Studies have found increased risks of gastrointestinal adverse events (biliary disease, 2 pancreatitis, 3 bowel obstruction, 4 and gastroparesis 5 ) in patients with diabetes. 2 - 5 Because such patients have higher baseline risk for gastrointestinal adverse events, risk in patients taking these drugs for other indications may differ. Randomized trials examining efficacy of GLP-1 agonists for weight loss were not designed to capture these events 2 due to small sample sizes and short follow-up. We examined gastrointestinal adverse events associated with GLP-1 agonists used for weight loss in a clinical setting.

We used a random sample of 16 million patients (2006-2020) from the PharMetrics Plus for Academics database (IQVIA), a large health claims database that captures 93% of all outpatient prescriptions and physician diagnoses in the US through the International Classification of Diseases, Ninth Revision (ICD-9) or ICD-10. In our cohort study, we included new users of semaglutide or liraglutide, 2 main GLP-1 agonists, and the active comparator bupropion-naltrexone, a weight loss agent unrelated to GLP-1 agonists. Because semaglutide was marketed for weight loss after the study period (2021), we ensured all GLP-1 agonist and bupropion-naltrexone users had an obesity code in the 90 days prior or up to 30 days after cohort entry, excluding those with a diabetes or antidiabetic drug code.

Patients were observed from first prescription of a study drug to first mutually exclusive incidence (defined as first ICD-9 or ICD-10 code) of biliary disease (including cholecystitis, cholelithiasis, and choledocholithiasis), pancreatitis (including gallstone pancreatitis), bowel obstruction, or gastroparesis (defined as use of a code or a promotility agent). They were followed up to the end of the study period (June 2020) or censored during a switch. Hazard ratios (HRs) from a Cox model were adjusted for age, sex, alcohol use, smoking, hyperlipidemia, abdominal surgery in the previous 30 days, and geographic location, which were identified as common cause variables or risk factors. 6 Two sensitivity analyses were undertaken, one excluding hyperlipidemia (because more semaglutide users had hyperlipidemia) and another including patients without diabetes regardless of having an obesity code. Due to absence of data on body mass index (BMI), the E-value was used to examine how strong unmeasured confounding would need to be to negate observed results, with E-value HRs of at least 2 indicating BMI is unlikely to change study results. Statistical significance was defined as 2-sided 95% CI that did not cross 1. Analyses were performed using SAS version 9.4. Ethics approval was obtained by the University of British Columbia’s clinical research ethics board with a waiver of informed consent.

Our cohort included 4144 liraglutide, 613 semaglutide, and 654 bupropion-naltrexone users. Incidence rates for the 4 outcomes were elevated among GLP-1 agonists compared with bupropion-naltrexone users ( Table 1 ). For example, incidence of biliary disease (per 1000 person-years) was 11.7 for semaglutide, 18.6 for liraglutide, and 12.6 for bupropion-naltrexone and 4.6, 7.9, and 1.0, respectively, for pancreatitis.

Use of GLP-1 agonists compared with bupropion-naltrexone was associated with increased risk of pancreatitis (adjusted HR, 9.09 [95% CI, 1.25-66.00]), bowel obstruction (HR, 4.22 [95% CI, 1.02-17.40]), and gastroparesis (HR, 3.67 [95% CI, 1.15-11.90) but not biliary disease (HR, 1.50 [95% CI, 0.89-2.53]). Exclusion of hyperlipidemia from the analysis did not change the results ( Table 2 ). Inclusion of GLP-1 agonists regardless of history of obesity reduced HRs and narrowed CIs but did not change the significance of the results ( Table 2 ). E-value HRs did not suggest potential confounding by BMI.

This study found that use of GLP-1 agonists for weight loss compared with use of bupropion-naltrexone was associated with increased risk of pancreatitis, gastroparesis, and bowel obstruction but not biliary disease.

Given the wide use of these drugs, these adverse events, although rare, must be considered by patients who are contemplating using the drugs for weight loss because the risk-benefit calculus for this group might differ from that of those who use them for diabetes. Limitations include that although all GLP-1 agonist users had a record for obesity without diabetes, whether GLP-1 agonists were all used for weight loss is uncertain.

Accepted for Publication: September 11, 2023.

Published Online: October 5, 2023. doi:10.1001/jama.2023.19574

Correction: This article was corrected on December 21, 2023, to update the full name of the database used.

Corresponding Author: Mahyar Etminan, PharmD, MSc, Faculty of Medicine, Departments of Ophthalmology and Visual Sciences and Medicine, The Eye Care Center, University of British Columbia, 2550 Willow St, Room 323, Vancouver, BC V5Z 3N9, Canada ( [email protected] ).

Author Contributions: Dr Etminan had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Sodhi, Rezaeianzadeh, Etminan.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Sodhi, Rezaeianzadeh, Etminan.

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Integrating information systems: case studies on current challenges

• General Research
• Published: 18 May 2010
• Volume 20 , pages 161–174, ( 2010 )

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• Alexander Schmidt 1 ,
• Boris Otto 1 &
• Hubert Österle 1  

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Integration of information systems is a prerequisite for efficient collaboration within and between organizations. Despite intensive research on integration issues in Information Systems research, companies nowadays still encounter considerable challenges in integration projects. The question for the reasons still engages researchers and practitioners. The paper at hand investigates current integration problems by deriving a framework for integration problems from literature research and applying it for the analysis of concrete cases from business practice. The examples are described in detail in explorative case studies examining three integration projects from different industries and with different objectives. From the comparison of theoretically derived and practically proven integration problems, the paper identifies integration problems that have been insufficiently addressed so far and discusses open challenges of integration in the Information Systems discipline.

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Model-based approaches for interoperability of next generation enterprise information systems: state of the art and future challenges.

Evaluation Frameworks for Information Systems Integration: From a Semiotic Lens

System Integration for Intelligent Systems

The name of the case study complies with the name of the corresponding consortial research project.

The integration problems described below apply generally to the processes of different enterprises, irrespective of whether this public process concept is used.

As a rule, enhancers function by using master data held on the inet logistics server, with the aid of which the missing information is derived by calculation algorithms (e.g. weight data calculation via goods receipt) and customer-specific assumptions (e.g. deriving a carrier’s Incoterms from historical data). However, this is not a perfect solution to the problem.

IDoc represents an proprietary SAP format for transferring data in a business transaction.

IFTMIN is an EDIFACT message format for the electronic transfer of transport and forwarding orders.

Case anonymized due to company’s communication policy.

For further information see http://www.ip-super.org/

For further information see http://www.tao-project.eu/index.html

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Acknowledgements

This research was carried within the Competence Center Corporate Data Quality (CC CDQ) at the Institute of Information Management at the University of St. Gallen. The CC CDQ is part of the research program Business Engineering at the University of St. Gallen (BE HSG).

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Schmidt, A., Otto, B. & Österle, H. Integrating information systems: case studies on current challenges. Electron Markets 20 , 161–174 (2010). https://doi.org/10.1007/s12525-010-0037-8

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DOI : https://doi.org/10.1007/s12525-010-0037-8

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• Vitamin D: Fact sheet for health professionals. Office of Dietary Supplements. https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/. Accessed Dec. 6, 2020.
• Vitamin D: Fact sheet for consumers. Office of Dietary Supplements. https://ods.od.nih.gov/factsheets/VitaminD-Consumer/. Accessed Dec. 6, 2020.
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• AskMayoExpert. Vitamin D deficiency. Mayo Clinic; 2017.
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• Gold J, et al. The role of vitamin D in cognitive disorders in older adults. US Neurology. 2018; doi:10.17925/USN.2018.14.1.41.
• Sultan S, et al. Low vitamin D and its association with cognitive impairment and dementia. Journal of Aging Research. 2020; doi:10.1155/2020/6097820.
• Pazirandeh S, et al. Overview of vitamin D. https://www.uptodate.com/contents/search. Accessed Dec. 13, 2020.
• Hassan-Smith ZK, et al. 25-hydroxyvitamin D3 and 1,25-dihydroxyvitamin D3 exerct distinct effects on human skeletal muscle function and gene expression. PLOS One. 2017; doi:10.1371/journal.pone.0170665.

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• Soil and water at or near waste sites - at landfills, disposal sites, and hazardous waste sites such as those that fall under the federal Superfund and Resource Conservation and Recovery Act programs.
• Fire extinguishing foam - in aqueous film-forming foams (or AFFFs) used to extinguish flammable liquid-based fires.  Such foams are used in training and emergency response events at airports, shipyards, military bases, firefighting training facilities, chemical plants, and refineries.
• Manufacturing or chemical production facilities that produce or use PFAS – for example at chrome plating, electronics, and certain textile and paper manufacturers.
• Food – for example in fish caught from water contaminated by PFAS and dairy products from livestock exposed to PFAS.
• Food packaging – for example in grease-resistant paper, fast food containers/wrappers, microwave popcorn bags, pizza boxes, and candy wrappers.
• Household products and dust – for example in stain and water-repellent used on carpets, upholstery, clothing, and other fabrics; cleaning products; non-stick cookware; paints, varnishes, and sealants.
• Personal care products – for example in certain shampoo, dental floss, and cosmetics.
• Biosolids – for example fertilizer from wastewater treatment plants that is used on agricultural lands can affect ground and surface water and animals that graze on the land.

People Can Be Exposed to PFAS in a Variety of Ways

Due to their widespread production and use, as well as their ability to move and persist in the environment, surveys conducted by the Centers for Disease Control and Prevention (CDC) show that most people in the United States have been exposed to some PFAS. Most known exposures are relatively low, but some can be high, particularly when people are exposed to a concentrated source over long periods of time. Some PFAS chemicals can accumulate in the body over time.

Current research has shown that people can be exposed to PFAS by:

• Working in occupations such as firefighting or chemicals manufacturing and processing.
• Drinking water contaminated with PFAS.
• Eating certain foods that may contain PFAS, including fish.
• Swallowing contaminated soil or dust.
• Breathing air containing PFAS.
• Using products made with PFAS or that are packaged in materials containing PFAS.

Exposure to PFAS May be Harmful to Human Health

Current scientific research suggests that exposure to certain PFAS may lead to adverse health outcomes. However, research is still ongoing to determine how different levels of exposure to different PFAS can lead to a variety of health effects. Research is also underway to better understand the health effects associated with low levels of exposure to PFAS over long periods of time, especially in children.

What We Know about Health Effects

Current peer-reviewed scientific studies have shown that exposure to certain levels of PFAS may lead to:

• Reproductive effects such as decreased fertility or increased high blood pressure in pregnant women.
• Developmental effects or delays in children, including low birth weight, accelerated puberty, bone variations, or behavioral changes.
• Increased risk of some cancers, including prostate, kidney, and testicular cancers.
• Reduced ability of the body’s immune system to fight infections, including reduced vaccine response.
• Interference with the body’s natural hormones.
• Increased cholesterol levels and/or risk of obesity.

Additional Health Effects are Difficult to Determine

Scientists at EPA, in other federal agencies, and in academia and industry are continuing to conduct and review the growing body of research about PFAS. However, health effects associated with exposure to PFAS are difficult to specify for many reasons, such as:

• There are thousands of PFAS with potentially varying effects and toxicity levels, yet most studies focus on a limited number of better known PFAS compounds.
• People can be exposed to PFAS in different ways and at different stages of their life.
• The types and uses of PFAS change over time, which makes it challenging to track and assess how exposure to these chemicals occurs and how they will affect human health. 

Certain Adults and Children May Have Higher Exposure to PFAS

Some people have higher exposures to PFAS than others because of their occupations or where they live. For example:

• Industrial workers who are involved in making or processing PFAS or PFAS-containing materials, or people who live or recreate near PFAS-producing facilities, may have greater exposure to PFAS.
• Pregnant and lactating women tend to drink more water per pound of body weight than the average person and as a result they may have higher PFAS exposure compared to other people if it is present in their drinking water.

Because children are still developing, they may be more sensitive to the harmful effects of chemicals such as PFAS. They can also be exposed more than adults because:

• Children drink more water, eat more food, and breathe more air per pound of body weight than adults, which can increase their exposure to PFAS.
• Young children crawl on floors and put things in their mouths which leads to a higher risk of exposure to PFAS in carpets, household dust, toys, and cleaning products.

Breast milk from mothers with PFAS in their blood and formula made with water containing PFAS can expose infants to PFAS, and it may also be possible for children to be exposed in utero during pregnancy.  Scientists continue to do research in this area. Based on current science, the benefits of breastfeeding appear to outweigh the risks for infants exposed to PFAS in breast milk . To weigh the risks and benefits of breastfeeding, mothers should contact their doctors.

Where to Go for the Latest Information on PFAS

News releases from epa about pfas.

Sign up to receive EPA’s press releases and alerts on PFAS related topics.

Federal Government Resources

• U.S. Environmental Protection Agency (EPA)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• National Institutes of Health (NIH) 
• Food and Drug Administration (FDA)
• United States Department of Defense (DOD)
• United States Navy
• United States Air Force, Civil Engineering Center

State Government Resources

• Association of State Drinking Water Administrators (ASDWA)
• Interstate Technology and Regulatory Council (ITRC)
• Environmental Council of the States (ECOS)
• Environmental Research Institute of the States (ERIS)

Information on How to Provide Input on Proposed Government Actions

What is a regulation.

Under federal environmental laws, EPA and other federal agencies are authorized to help put those laws into effect by creating and enforcing regulations.

Regulations are mandatory requirements that can apply to individuals, businesses, state or local governments, non-profits, and others.

Federal agencies are required to provide an opportunity for public comment when proposing a new regulation and must consider the comments in revising the proposal and issuing a final rule.  In carrying out our mission to protect human health and the environment, EPA develops regulations to prevent or to clean up hazardous chemicals released into our air, land, and water, some of which relate to PFAS. 

Commenting on a proposed regulation is an important opportunity to make your voice heard. It is a way for you to provide decisionmakers with key information on any or all aspects of the proposed action, including:

• Pointing out key issues in the proposed regulation that you or your community are concerned about,
• Offering additional data and scientific evidence that may not have been considered,
• Identifying factual errors, and
• Proposing alternative solutions.  

EPA’s regulations will always be announced in the Federal Register and can be found at the following government websites: https://www.federalregister.gov/ , and https://www.regulations.gov/ .

For some rules, EPA holds a public hearing where you can provide comments in person or remotely. The agency always accepts comments in writing. All comments – whether in person or written – get the same level of consideration. Below are additional resources to help you comment on EPA’s proposed regulations related to PFAS.

• Learn how to get involved with EPA regulations .
• Read tips for submitting effective comments on EPA’s proposed regulations .
• Watch a webinar on “Techniques and Skills for Providing Effective Input in the EPA Rulemaking Process.”
• EPA's Current Understanding
• Increasing Our Understanding
• Action Steps to Reduce Risk
• EPA Actions to Address PFAS
• PFAS Strategic Roadmap
• Data and Tools
• State Information