# Cannabis News and Regulatory Roundup: Clinical correlates of homelessness and… > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/cannabis-news-and-regulatory-roundup-clinical-correlates-of-homelessness-oct-2026/ > **Published:** 2026-10-04T09:38:13-04:00 | **Last Modified / Clinically Audited:** 2026-10-04T09:38:13-04:00 > **Clinical Summary:** cannabis news digest: CED Clinic analysis of 3 recent cannabis policy, science, and regulatory developments with Dr. Benjamin Caplan. --- CED Clinical Relevance #65 Verified Overview Curated multi-source overview preserving 3 verified developments. Clinical Insight | CED Clinic The strongest signal here is not that cannabis explains homelessness, but that the overlap of the two identifies a clinically fragile subgroup with layered risk. In low-income veterans, the combination was associated with more trauma, current PTSD and generalized anxiety, suicidality, arrests, eviction, gambling, and polydrug use, especially stimulants. That pattern argues for integrated care, where housing instability, behavioral health, and substance use are assessed together. The other two papers cannot be interpreted from the supplied abstracts, so they should not be used to support claims about cannabis warnings or inflammatory biomarkers without the missing methods and results. DigestCannabis NewsRegulationPublic HealthClinical Practice AudiencePatients, clinicians, healthcare professionals, regulators, and industry researchers. Primary TopicCurated updates on Clinical correlates of homelessness and cannabis u. Source[Read the full source](https://pubmed.ncbi.nlm.nih.gov/42828953/) Table of Contents - [Cannabis News and Regulatory Roundup: Clinical correlates of homelessness and…](#Cannabis_News_and_Regulatory_Roundup_Clinical_correlates_of_homelessness_and8230)[How to Interpret This Cannabis News and Regulatory Roundup](#How_to_Interpret_This_Cannabis_News_and_Regulatory_Roundup)[Three Rules for Critical Reading](#Three_Rules_for_Critical_Reading) - [CED Perspective Lens: Eight Viewpoints on These Updates](#CED_Perspective_Lens_Eight_Viewpoints_on_These_Updates)[What this means for a patient](#What_this_means_for_a_patient) - [What a clinician should do](#What_a_clinician_should_do) - [Safety and harm reduction](#Safety_and_harm_reduction) - [What this suggests for policy](#What_this_suggests_for_policy) - [What the evidence base still needs](#What_the_evidence_base_still_needs) - [Reasons to be cautious](#Reasons_to_be_cautious) - [What families and support people should notice](#What_families_and_support_people_should_notice) - [Bottom line](#Bottom_line) - [Frequently Asked Questions](#Frequently_Asked_Questions)[Related](#Related) # Cannabis News and Regulatory Roundup: Clinical correlates of homelessness and… A structured CED Clinic overview of 3 key developments in cannabis regulation, market milestones, and scientific research. What This Study Teaches Us Study 1, a nationally representative sample of 1,031 low-income U.S. veterans, found 235 veterans with either lifetime homelessness, lifetime cannabis use, or both, and the combined homelessness plus cannabis group was the highest-risk subgroup. Compared with cannabis use alone, the homelessness plus cannabis group had more trauma burden, current PTSD and generalized anxiety disorder, suicidal behavior, arrest history, and eviction, while compared with homelessness alone it was more strongly linked to current gambling; cannabis use also tracked with living in states where cannabis was legalized. Study 2 and Study 3 are listed as open-access publications, but the provided abstracts do not include sample sizes, endpoints, or results, so no empirical findings can be responsibly extracted from the material supplied. Why This Matters For veterans with unstable housing, cannabis use may be a marker for a broader cluster of trauma, psychiatric illness, legal problems, and polysubstance exposure, not an isolated behavior. That matters because harm reduction in this setting has to include screening for PTSD, anxiety, suicidality, stimulant use, and eviction risk, not just asking whether cannabis is being used. Study SnapshotPost TypeCannabis News and Regulatory Roundup using canonical CED layoutItems Reviewed3 verified updatesPrimary DatesOctober 04, 2026Related Reading3 verified live CED Clinic internal linksStudy 1Clinical correlates of homelessness and (Stefanovics et al., Journal of psychiatric research) [DOI: 10.1016/j.jpsychires.2026.09.028 | PMID: 42828953]Study 2Inside the regulatory process of develop (Ranney et al., Journal of Cannabis Research) [DOI: 10.1186/s42238-026-00516-7]Study 3Comparative plasma pro-inflammatory cyto (Sande et al., BMC Research Notes) [DOI: 10.1186/s13104-026-08042-8] Clinical Bottom Line This cannabis news and regulatory roundup preserves key signals across 3 updates without overstatement, offering grounded guidance for patients and practitioners. Digest Contents - [Digest Card 1 | Clinical correlates of homelessness and cannabis u](#digest-card-2-digest-card-1-clinical-correlates-of-homelessness-and-cannabis-u) - [Digest Card 2 | Inside the regulatory process of developing and im](#digest-card-3-digest-card-2-inside-the-regulatory-process-of-developing-and-im) - [Digest Card 3 | Comparative plasma pro-inflammatory cytokine level](#digest-card-4-digest-card-3-comparative-plasma-pro-inflammatory-cytokine-level) Why These 3 Updates Belong Together This curated cannabis news and regulatory roundup brings together 3 key developments across policy, market milestones, and health regulations. Analyzing these distinct updates in one structured overview clarifies emerging patterns while respecting the specific boundaries of each report. Rather than overextending any single announcement or preliminary finding into an oversized headline, grouping verified updates enables readers and clinicians to track the broader direction of the field with precision. Digest Card 1 | Clinical correlates of homelessness and cannabis u **Title & Source:** [Clinical correlates of homelessness and cannabis use among U.S. low-income veterans.](https://pubmed.ncbi.nlm.nih.gov/42828953/) (*Journal of psychiatric research*, 2026Sep29) **Lead Authors & Identifiers:** Elina A Stefanovics, Marc N Potenza, Jack Tsai. | **Primary Record:** DOI: 10.1016/j.jpsychires.2026.09.028 | PMID: 42828953 Content lane: **Evidence Check**. **1. Scientific & Clinical Background:** This was a nationally representative analysis of 1,031 low-income U.S. veterans examining lifetime homelessness and lifetime cannabis use. The 235 veterans with either exposure were divided into three groups: homelessness only (n = 27), cannabis use only (n = 174), and both homelessness plus cannabis use (n = 34). **2. Detailed Findings & Primary Data:** The combined homelessness plus cannabis group had the heaviest clinical burden. Compared with cannabis use alone, it was more strongly associated with arrests, poor subjective health, more drugs used, higher trauma burden, current PTSD, current generalized anxiety disorder, suicidal behavior, history of arrest, and eviction; compared with homelessness alone, it was more strongly associated with current gambling. Cannabis use also correlated with living in states where cannabis was legalized, and the combined group had particularly common stimulant use. **3. Dr. Caplan’s Clinical & Practical Guidance:** This pattern should prompt broad screening, not a narrow cannabis-only conversation. In veterans with housing instability, ask about trauma, suicidality, stimulant use, gambling, and legal stress, then connect care across behavioral health and social supports. **4. Study Boundaries & Methodological Limits:** The study is observational and cross-sectional, so it cannot establish directionality or causation. The combined subgroup was small, and the sample was limited to low-income veterans, which constrains generalizability. Digest Card 2 | Inside the regulatory process of developing and im **Title & Source:** [Inside the regulatory process of developing and implementing cannabis warnings: a qualitative study](https://doi.org/10.1186/s42238-026-00516-7) (*Journal of Cannabis Research*, 2026-10-03) **Lead Authors & Identifiers:** Leah M. Ranney, Sonia A Clark, Megan J. Faber, Tyler A West et al.. | **Primary Record:** DOI: 10.1186/s42238-026-00516-7 Content lane: **Clinical Evidence Update**. **1. Scientific & Clinical Background:** The supplied record identifies a qualitative study on the regulatory process of developing and implementing cannabis warnings, published in the Journal of Cannabis Research. No abstract text, sample description, or methods were provided in the material here. **2. Detailed Findings & Primary Data:** No quantitative findings can be extracted in the published report. The absence of endpoints, participant numbers, and results means there is no basis here for judging what the study found about warning development, implementation, or impact. **3. Dr. Caplan’s Clinical & Practical Guidance:** Do not use this citation to support a specific warning policy or patient counseling point without the full paper. If the study is meant to inform practice, the missing abstract and results need to be reviewed before drawing conclusions. **4. Study Boundaries & Methodological Limits:** Because the abstract is not available in the supplied material, the study cannot be appraised for design quality, bias, or relevance. Its clinical meaning is indeterminate from this packet. Digest Card 3 | Comparative plasma pro-inflammatory cytokine level **Title & Source:** [Comparative plasma pro-inflammatory cytokine levels in people living with HIV who use opioids and cannabis concurrently versus non-users in Kampala, Uganda: a cross-sectional study](https://doi.org/10.1186/s13104-026-08042-8) (*BMC Research Notes*, 2026-10-03) **Lead Authors & Identifiers:** Obondo James Sande, Nsawa Ivan Samuel, Tracy Kongai, Khaver Bashir et al.. | **Primary Record:** DOI: 10.1186/s13104-026-08042-8 Content lane: **Clinical Evidence Update**. **1. Scientific & Clinical Background:** The supplied record identifies a cross-sectional study in people living with HIV in Kampala, Uganda, comparing plasma pro-inflammatory cytokine levels among concurrent opioid and cannabis users versus non-users. No abstract text, sample size, or biomarker results were provided in the material here. **2. Detailed Findings & Primary Data:** No quantitative outcomes can be responsibly reported from the supplied summary. The key biomarker endpoints, group sizes, and statistical comparisons are missing, so the study cannot be interpreted from this packet. **3. Dr. Caplan’s Clinical & Practical Guidance:** Do not infer that cannabis, opioids, or their combination alters inflammatory markers in HIV from the citation alone. The full abstract and methods are needed before this study can inform counseling or biomarker interpretation. **4. Study Boundaries & Methodological Limits:** The absence of results prevents assessment of effect size, confounding, and clinical significance. Without the full abstract, the study remains uninterpretable for clinical decision-making. How Strong Is This Evidence? Study 1 is the only paper with usable quantitative detail here, and it is a nationally representative observational analysis with multivariable comparisons across 235 veterans in three exposure groups. That gives it moderate descriptive strength for association, but not causal inference. Studies 2 and 3 cannot be graded in the published report because the abstracts, sample sizes, and outcomes are absent, which makes their evidentiary value indeterminate from this packet. Where This Paper Deserves Skepticism Study 1 is cross-sectional and relies on lifetime histories, so temporality is unclear, cannabis use may predate or follow homelessness, and unmeasured confounding is likely substantial. The sample is also restricted to low-income veterans, which limits generalizability, and the combined group was small at n = 34, making subgroup estimates vulnerable to instability. For studies 2 and 3, the absence of abstract-level data prevents any meaningful appraisal of bias, measurement quality, or statistical validity. What This Paper Does Not Show These papers do not prove that cannabis use causes homelessness, eviction, arrests, PTSD, or suicidality. They also do not establish that cannabis legalization itself worsens outcomes, only that cannabis use was more common among veterans living in legalized states in this sample. How This Fits With the Broader Clinical Conversation This fits a broader clinical shift toward treating cannabis use as one part of a syndemic that often includes trauma, housing insecurity, and other substance use rather than as a standalone exposure. It also underscores why current cannabis policy debates increasingly need real-world outcome data, especially in high-risk populations where legal access, potency, and patterns of use may interact with psychiatric vulnerability. Editorial Commentary *When a veteran has both homelessness history and cannabis use, I do not read that as a simple substance-use story. I read it as a signal to look harder for trauma, anxiety, sleep disruption, stimulant use, legal stress, and safety concerns. The cannabis may be part of coping, but it may also be sitting inside a much larger risk picture that needs active, coordinated care.* *The practical move is not to moralize the cannabis use, it is to widen the frame. Ask what the person is using, why, how often, what else is in the picture, and whether housing, PTSD, or suicidality are driving the pattern. If those pieces are missed, the cannabis conversation becomes too narrow to be useful.* What a Careful Reader Should Take Away Treat cannabis use in unstably housed veterans as a marker for broader clinical complexity, not a standalone diagnosis. Screen for trauma, suicidality, polysubstance use, and housing instability before making any assumptions about causality or risk. [https://cedclinic.com/ask](https://cedclinic.com/ask)Ask about these updates:[🧠Anxiety and Mood](https://cedclinic.com/ask)[🔥Inflammation](https://cedclinic.com/ask)[🏛️Law and Policy](https://cedclinic.com/ask) Evidence Interpretation Guide ## How to Interpret This Cannabis News and Regulatory Roundup The usable evidence here comes from one observational veteran study with clear subgroup differences, while the other two papers cannot be evaluated from the abstract text provided. That means the safest reading is to focus on the concrete associations in the veteran sample and avoid overclaiming about regulation or biomarkers. ### Three Rules for Critical Reading **1) Separate association from causation**In the veteran study, homelessness plus cannabis use tracked with PTSD, anxiety, suicidality, arrest, eviction, gambling, and stimulant use, but the design was cross-sectional. That means the data show clustering, not directionality, so cannabis cannot be blamed for the social and psychiatric burden on its own. **2) Pay attention to subgroup size and setting**The combined homelessness plus cannabis group was only 34 veterans, inside a low-income veteran sample of 1,031. That is useful for identifying a high-risk clinical phenotype, but it is not strong enough to support broad population claims without replication in other cohorts. **3) Do not infer results from missing abstracts**The two open-access papers listed here do not include sample sizes, endpoints, or findings in the supplied material. Without those details, they cannot be used to support clinical or policy conclusions about cannabis warnings or inflammatory effects. Key Evaluation Question Do these data show a causal effect of cannabis, or do they mainly identify a high-risk cluster of trauma, housing instability, and polysubstance use? The Patient Question If I use cannabis and I have housing stress, trauma, or other substance use, what else should we screen for so we do not miss a bigger problem? The Bottom Line The veteran study is a useful risk signal, not proof of harm from cannabis alone, and the other two papers cannot be judged from the information provided. CED Perspective Lens ## CED Perspective Lens: Eight Viewpoints on These Updates Why these developments matter across clinical, patient, safety, and policy perspectives Lens OverviewEight distinct clinical and regulatory perspectives on Clinical correlates of homelessness and canna. #### What this means for a patient For a veteran with housing instability, cannabis use may be part of coping, but it can also sit alongside trauma, anxiety, suicidality, stimulant use, and legal trouble. The study suggests that when homelessness and cannabis use overlap, the overall risk picture is broader than either issue alone. A patient should expect a clinician to ask about sleep, PTSD, panic, gambling, other drugs, and safety, not just cannabis frequency. That broader conversation is more likely to find the real driver of symptoms and the right support. Lens takeawayCannabis use in unstable housing often signals broader needs that deserve attention. #### What a clinician should do Use the homelessness plus cannabis pattern as a trigger for integrated screening, especially for PTSD, generalized anxiety, suicidality, stimulant use, and eviction risk. The subgroup with both exposures had the heaviest burden, so a narrow substance-use lens will miss important comorbidity. The practical response is coordinated care, not single-issue counseling. Housing support, behavioral health, and substance-use treatment should be considered together, especially when gambling or polysubstance use is present. Grounding clinical discussions in verified study designs equips healthcare professionals to address patient inquiries with nuanced context and realistic expectations. Lens takeawayScreen broadly and connect housing, trauma, and substance-use care in one plan. #### Safety and harm reduction The study links the combined homelessness plus cannabis group with suicidal behavior, arrests, and more drugs used, which raises immediate safety concerns. That makes it important to assess current risk, access to support, and whether the person is using stimulants or other substances that increase instability. Harm reduction here means more than advising lower cannabis use. It means checking for acute psychiatric risk, overdose risk from polysubstance exposure, and whether the person has a safe place to sleep and a way to reach care. Lens takeawaySafety screening should include suicidality, polysubstance use, and housing stability. #### What this suggests for policy The finding that cannabis use was more common among veterans living in legalized states does not prove legalization caused harm, but it does show that policy changes can alter exposure patterns. That matters because high-risk groups may experience legalization differently than the general population. Policy discussions should not stop at access or tax revenue. They need to account for trauma burden, homelessness, and behavioral health service capacity, especially in veteran populations where the clinical stakes are high. Consistent administrative oversight, clear statutory definitions, and transparent regulatory frameworks ensure that public health protections keep pace with evolving consumer formulations. Lens takeawayPolicy should be judged by real-world outcomes in vulnerable groups, not slogans. #### What the evidence base still needs The veteran study is useful but still observational, and the other two papers cannot be evaluated from the supplied abstracts. Future work needs longitudinal designs that can sort out whether cannabis use precedes homelessness, follows it, or simply clusters with it. The field also needs better biomarker and regulatory studies with transparent methods and complete reporting. Without sample sizes, endpoints, and effect estimates, the clinical value of those papers remains unknown. Further methodologically rigorous prospective trials with longitudinal follow-up and standardized formulations are needed to confirm initial mechanistic observations. Lens takeawayLongitudinal, fully reported studies are needed before strong claims can be made. #### Reasons to be cautious The combined homelessness plus cannabis subgroup had only 34 veterans, which makes estimates fragile. Cross-sectional lifetime histories also invite recall bias and make it impossible to know whether cannabis use, homelessness, or another factor came first. The sample was limited to low-income veterans, so the findings may not generalize to other populations. The missing abstracts for the other two studies make them impossible to appraise at all from the provided material. Readers should carefully weigh sample sizes, risk ratios, exposure confirmation methods, and potential confounders before generalizing preliminary findings to routine practice. Lens takeawaySmall subgroups and missing methods limit how far these findings can be stretched. #### What families and support people should notice If someone has housing instability and uses cannabis, family members should watch for worsening anxiety, sleep problems, gambling, stimulant use, or talk of hopelessness. Those are the kinds of co-occurring issues this study suggests may travel together. Support is most useful when it is practical and specific, helping with appointments, housing resources, and crisis planning. The goal is to reduce isolation and catch escalating risk early. Practical safety measures, structured routines, and secure product storage help maintain a supportive, predictable, and safe home environment for vulnerable individuals. Lens takeawayLook for the cluster, not just the cannabis use itself. #### Bottom line The clearest evidence here shows that homelessness plus cannabis use in low-income veterans marks a group with more trauma, psychiatric illness, legal problems, and polysubstance use. That is a clinical warning sign, not proof that cannabis is the cause. The other two papers cannot be interpreted from the supplied abstracts, so they should not shape practice until the full methods and results are available. Careful reading means staying with what is actually reported. Evaluating primary scientific data with clinical discipline ensures that therapeutic decisions remain balanced, evidence-informed, and grounded in reproducible outcomes. Lens takeawayUse the data to widen assessment, not to overstate causality. Join the Conversation Have a question about how this applies to your situation? [Ask Dr. Caplan](https://benjamincaplan.com/ask-dr-caplan) Want to discuss this topic with other patients and caregivers? [Join the forum discussion](https://cedclinic.com/interact/discussion-forums/forum/cannabis-industry/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Physician-Led, Whole-Person Care A doctor who takes the time to truly understand you. Personal care that starts with listening and is guided by experience and ingenuity. Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](http://CEDclinic.com/book) [Cannabis Care](http://CEDclinic.com/book) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Share this Evidence Watch [X](https://twitter.com/intent/tweet?text=Cannabis+News+and+Regulatory+Roundup%3A+Clinical+correlates+of+homelessness+and...&url=https%3A%2F%2Fcedclinic.com%2Fcannabis-news-and-regulatory-roundup-clinical-correlates-of-homelessness-oct-2026%2F) [LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fcedclinic.com%2Fcannabis-news-and-regulatory-roundup-clinical-correlates-of-homelessness-oct-2026%2F) [BlueSky](https://bsky.app/intent/compose?text=Cannabis+News+and+Regulatory+Roundup%3A+Clinical+correlates+of+homelessness+and...%20https%3A%2F%2Fcedclinic.com%2Fcannabis-news-and-regulatory-roundup-clinical-correlates-of-homelessness-oct-2026%2F) [Instagram](https://www.instagram.com/drcaplan/) [Substack](https://doctorapprovedcannabis.substack.com/) [RSS](https://cedclinic.com/feed/) Source: [Primary Sources: Journal of psychiatric research, Journal of Cannabis Research, BMC Research Notes](https://pubmed.ncbi.nlm.nih.gov/42828953/) Related Reading at CED ClinicContinue exploring the evidence[The Multifaceted Impact of CBD on Sleep: A Comprehensive Guide for Better Rest](https://cedclinic.com/the-multifaceted-impact-of-cbd-on-sleep-a-comprehensive-guide-for-better-rest/) More on this topic: Clinical insights into sleep architecture, circadian rhythm modulation, and cannabinoid titration for insomnia. [More on this topic: Cannabinoids & sleep](https://cedclinic.com/the-multifaceted-impact-of-cbd-on-sleep-a-comprehensive-guide-for-better-rest/)[Cannabis Use Disorder Is Rising Among US Adults](https://cedclinic.com/cannabis-use-disorder-rising-us-adults-2026/) More on this topic: Epidemiological evaluation of diagnostic trends, screening tools, and evidence-based patient counseling. [More on this topic: CUD trends & screening](https://cedclinic.com/cannabis-use-disorder-rising-us-adults-2026/)[Prenatal Cannabis Use and Motivation to Quit: What a New Study Found](https://cedclinic.com/prenatal-cannabis-quit-motivation-study/) More on this topic: Dr. Caplan evaluates pregnant patients’ motivation to stop or reduce cannabis use, clinical cessation discussions, and quitline uptake barriers. [More on this topic: Prenatal quit motivation](https://cedclinic.com/prenatal-cannabis-quit-motivation-study/) ## Frequently Asked Questions What is covered in this cannabis news and regulatory roundup? This edition reviews 3 verified developments across cannabis policy, regulatory oversight, and clinical science. How are stories selected for CED digests? Stories are curated from official primary sources, government agency dockets, and peer-reviewed journals, focusing on practical relevance for patients and clinicians. Do preliminary reports establish medical efficacy? No. Observational reports, preprints, and regulatory filings describe emerging trends and require formal clinical trials before treatment efficacy can be claimed. How should clinicians use these updates? Clinicians can use these updates to understand patient questions, stay current with state regulations, and maintain evidence-informed counseling. Where can readers find Dr. Caplan's clinical insights? Dr. Caplan provides comprehensive clinical perspectives, patient consultations, and educational resources at CEDclinic.com. Why are multi-topic digests published instead of single stories? Digests group related updates together to provide a broader thematic overview while preserving important nuances and methodological limits. What is the primary role of laboratory testing in cannabis policy? Laboratory testing verifies cannabinoid potency and screens for harmful contaminants like heavy metals, pesticides, and molds to protect consumer health. How do state regulatory milestones impact [patient access](https://cedclinic.com/tsa-rules-on-cbd-gummies-travel-guidelines-2026/)? Administrative milestones establish the licensing rules, product categories, and retail standards that determine how and where registered patients obtain care. What precautions should families take with medical cannabis at home? Families should keep all medical cannabis products securely locked in child-resistant containers and clearly labeled to avoid accidental exposure. How often does CED Clinic publish clinical and policy updates? CED Clinic publishes regular morning, afternoon, and evening evidence reviews and news digests to keep the community informed. ### Related --- ### Verification & Medical Governance - **Lead Clinical Author:** Benjamin Caplan, MD - **Credentials:** Board Certified in Family Medicine (ABFM), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House). - **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`). - **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/). - **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637). - **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).