surveillance

Surveillance of Omadacycline Activity Tested against Clinical Isolates from the United States and Europe: Report from the SENTRY Antimicrobial Surveillance Program, 2016 to 2018 [Epidemiology and Surveillance]

Omadacycline is a broad-spectrum aminomethylcycline approved in October 2018 by the U.S. Food and Drug Administration for treating acute bacterial skin and skin structure infections and community-acquired pneumonia as both an oral and intravenous once-daily formulation. In this report, the activities of omadacycline and comparators were tested against 49,000 nonduplicate bacterial isolates collected prospectively during 2016 to 2018 from medical centers in Europe (24,500 isolates, 40 medical centers [19 countries]) and the United States (24,500 isolates, 33 medical centers [23 states and all 9 U.S. census divisions]). Omadacycline was tested by broth microdilution following the methods in Clinical and Laboratory Standards Institute document M07 (Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, 11th ed., 2018). Omadacycline (MIC50/90, 0.12/0.25 mg/liter) inhibited 98.6% of Staphylococcus aureus isolates at ≤0.5 mg/liter, including 96.3% of methicillin-resistant S. aureus isolates and 99.8% of methicillin-susceptible S. aureus isolates. Omadacycline potency was comparable for Streptococcus pneumoniae (MIC50/90, 0.06/0.12 mg/liter), viridans group streptococci (MIC50/90, 0.06/0.12 mg/liter), and beta-hemolytic streptococci (MIC50/90, 0.12/0.25 mg/liter), regardless of species and susceptibility to penicillin, macrolides, or tetracycline. Omadacycline was active against all Enterobacterales tested (MIC50/90, 1/8 mg/liter; 87.5% of isolates were inhibited at ≤4 mg/liter) except Proteus mirabilis (MIC50/90, 16/>32 mg/liter) and indole-positive Proteus spp. (MIC50/90, 8/32 mg/liter) and was most active against Escherichia coli (MIC50/90, 0.5/2 mg/liter), Klebsiella oxytoca (MIC50/90, 1/2 mg/liter), and Citrobacter spp. (MIC50/90, 1/4 mg/liter). Omadacycline inhibited 92.4% of Enterobacter cloacae species complex and 88.5% of Klebsiella pneumoniae isolates at ≤4 mg/liter. Omadacycline was active against Haemophilus influenzae (MIC50/90, 0.5/1 mg/liter), regardless of β-lactamase status, and against Moraxella catarrhalis (MIC50/90, ≤0.12/0.25 mg/liter). The potent activity of omadacycline against Gram-positive and -negative bacteria indicates that omadacycline merits further study in serious infections in which multidrug resistance and mixed Gram-positive and Gram-negative bacterial infections may be a concern.




surveillance

Genomic Characterization of Neisseria gonorrhoeae Strains from 2016 U.S. Sentinel Surveillance Displaying Reduced Susceptibility to Azithromycin [Epidemiology and Surveillance]

In 2016, the proportion of Neisseria gonorrhoeae isolates with reduced susceptibility to azithromycin rose to 3.6%. A phylogenetic analysis of 334 N. gonorrhoeae isolates collected in 2016 revealed a single, geographically diverse lineage of isolates with MICs of 2 to 16 μg/ml that carried a mosaic-like mtr locus, whereas the majority of isolates with MICs of ≥16 μg/ml appeared sporadically and carried 23S rRNA mutations. Continued molecular surveillance of N. gonorrhoeae isolates will identify new resistance mechanisms.




surveillance

Using Genetic Distance from Archived Samples for the Prediction of Antibiotic Resistance in Escherichia coli [Epidemiology and Surveillance]

The rising rates of antibiotic resistance increasingly compromise empirical treatment. Knowing the antibiotic susceptibility of a pathogen’s close genetic relative(s) may improve empirical antibiotic selection. Using genomic and phenotypic data for Escherichia coli isolates from three separate clinically derived databases, we evaluated multiple genomic methods and statistical models for predicting antibiotic susceptibility, focusing on potentially rapidly available information, such as lineage or genetic distance from archived isolates. We applied these methods to derive and validate the prediction of antibiotic susceptibility to common antibiotics. We evaluated 968 separate episodes of suspected and confirmed infection with Escherichia coli from three geographically and temporally separated databases in Ontario, Canada, from 2010 to 2018. Across all approaches, model performance (area under the curve [AUC]) ranges for predicting antibiotic susceptibility were the greatest for ciprofloxacin (AUC, 0.76 to 0.97) and the lowest for trimethoprim-sulfamethoxazole (AUC, 0.51 to 0.80). When a model predicted that an isolate was susceptible, the resulting (posttest) probabilities of susceptibility were sufficient to warrant empirical therapy for most antibiotics (mean, 92%). An approach combining multiple models could permit the use of narrower-spectrum oral agents in 2 out of every 3 patients while maintaining high treatment adequacy (~90%). Methods based on genetic relatedness to archived samples of E. coli could be used to predict antibiotic resistance and improve antibiotic selection.




surveillance

Activity of Imipenem-Relebactam against Carbapenem-Resistant Escherichia coli Isolates from the United States in Relation to Clonal Background, Resistance Genes, Coresistance, and Region [Epidemiology and Surveillance]

Imipenem-relebactam (I-R) is a recently developed carbapenem–beta-lactamase inhibitor combination agent that can overcome carbapenem resistance, which has now emerged in Escherichia coli, including sequence type 131 (ST131) and its fluoroquinolone-resistant H30R subclone, the leading cause of extraintestinal E. coli infections globally. To clarify the likely utility of I-R for carbapenem-resistant (CR) E. coli infections in the United States, we characterized 203 recent CR clinical E. coli isolates from across the United States (years 2002 to 2017) for phylogroup, clonal group (including ST131, H30R, and the CTX-M-15-associated H30Rx subset within H30R), relevant beta-lactamase genes, and broth microdilution MICs for I-R and 11 comparator agents. Overall, I-R was highly active (89% susceptible), more so than all comparators except tigecycline and colistin (both 99% susceptible). I-R’s activity varied significantly in relation to phylogroup, clonal background, resistance genotype, and region. It was greatest among phylogroup B2, ST131-H30R, H30Rx, Klebsiella pneumoniae carbapenemase (KPC)-positive, and northeast U.S. isolates and lowest among phylogroup C, New Delhi metallo-β-lactamase (NDM)-positive, and southeast U.S. isolates. Relebactam improved imipenem’s activity against CR isolates within each phylogroup—especially groups A, B1, and B2—and particularly against isolates containing KPC. I-R remained substantially active against isolates coresistant to comparator agents, albeit somewhat less so than against the corresponding susceptible isolates. These findings suggest that I-R should be useful for treating most CR E. coli infections in the United States, largely independent of coresistance, although this likely will vary in relation to the local prevalence of specific E. coli lineages and carbapenem resistance mechanisms.




surveillance

Genomic Epidemiology of Complex, Multispecies, Plasmid-Borne blaKPC Carbapenemase in Enterobacterales in the United Kingdom from 2009 to 2014 [Epidemiology and Surveillance]

Carbapenem resistance in Enterobacterales is a public health threat. Klebsiella pneumoniae carbapenemase (encoded by alleles of the blaKPC family) is one of the most common transmissible carbapenem resistance mechanisms worldwide. The dissemination of blaKPC historically has been associated with distinct K. pneumoniae lineages (clonal group 258 [CG258]), a particular plasmid family (pKpQIL), and a composite transposon (Tn4401). In the United Kingdom, blaKPC has represented a large-scale, persistent management challenge for some hospitals, particularly in North West England. The dissemination of blaKPC has evolved to be polyclonal and polyspecies, but the genetic mechanisms underpinning this evolution have not been elucidated in detail; this study used short-read whole-genome sequencing of 604 blaKPC-positive isolates (Illumina) and long-read assembly (PacBio)/polishing (Illumina) of 21 isolates for characterization. We observed the dissemination of blaKPC (predominantly blaKPC-2; 573/604 [95%] isolates) across eight species and more than 100 known sequence types. Although there was some variation at the transposon level (mostly Tn4401a, 584/604 [97%] isolates; predominantly with ATTGA-ATTGA target site duplications, 465/604 [77%] isolates), blaKPC spread appears to have been supported by highly fluid, modular exchange of larger genetic segments among plasmid populations dominated by IncFIB (580/604 isolates), IncFII (545/604 isolates), and IncR (252/604 isolates) replicons. The subset of reconstructed plasmid sequences (21 isolates, 77 plasmids) also highlighted modular exchange among non-blaKPC and blaKPC plasmids and the common presence of multiple replicons within blaKPC plasmid structures (>60%). The substantial genomic plasticity observed has important implications for our understanding of the epidemiology of transmissible carbapenem resistance in Enterobacterales for the implementation of adequate surveillance approaches and for control.




surveillance

Comparison of Commensal and Clinical Isolates for Diversity of Plasmids in Escherichia coli and Klebsiella pneumoniae [Epidemiology and Surveillance]

In this study, the plasmid content of clinical and commensal strains was analyzed and compared. The replicon profile was similar in both populations, except for L, M, A/C, and N (detected only in clinical strains) and HI1 (only in commensal strains). Although I1 and F were the most frequent replicons, only IncI1, sequence type 12 (ST12) was associated with blaCMY-2 in both populations. In contrast, the widespread resistant IncF plasmids were not linked to a single epidemic plasmid.




surveillance

Novel Insights into Plasmodium vivax Therapeutic Failure: CYP2D6 Activity and Time of Exposure to Malaria Modulate the Risk of Recurrence [Epidemiology and Surveillance]

Plasmodium vivax relapse is one of the major causes of sustained global malaria transmission. Primaquine (PQ) is the only commercial drug available to prevent relapses, and its efficacy is dependent on metabolic activation by cytochrome P450 2D6 (CYP2D6). Impaired CYP2D6 function, caused by allelic polymorphisms, leads to the therapeutic failure of PQ as a radical cure for P. vivax malaria. Here, we hypothesized that the host immune response to malaria parasites modulates susceptibility to P. vivax recurrences in association with CYP2D6 activity. We performed a 10-year retrospective study by genotyping CYP2D6 polymorphisms in 261 malaria-exposed individuals from the Brazilian Amazon. The immune responses against a panel of P. vivax blood-stage antigens were evaluated by serological assays. We confirmed our previous findings, which indicated an association between impaired CYP2D6 activity and a higher risk of multiple episodes of P. vivax recurrence (risk ratio, 1.75; 95% confidence interval [CI], 1.2 to 2.6; P = 0.0035). An important finding was a reduction of 3% in the risk of recurrence (risk ratio, 0.97; 95% CI, 0.96 to 0.98; P < 0.0001) per year of malaria exposure, which was observed for individuals with both reduced and normal CYP2D6 activity. Accordingly, subjects with long-term malaria exposure and persistent antibody responses to various antigens showed fewer episodes of malaria recurrence. Our findings have direct implications for malaria control, since it was shown that nonimmune individuals who do not respond adequately to treatment due to reduced CYP2D6 activity may present a significant challenge for sustainable progress toward P. vivax malaria elimination.




surveillance

Distinct Mechanisms of Dissemination of NDM-1 Metallo-{beta}-Lactamase in Acinetobacter Species in Argentina [Epidemiology and Surveillance]

A 4-year surveillance of carbapenem-resistant Acinetobacter spp. isolates in Argentina identified 40 strains carrying blaNDM-1. Genome sequencing revealed that most were Acinetobacter baumannii, whereas seven represented other Acinetobacter spp. The A. baumannii genomes were closely related, suggesting recent spread. blaNDM-1 was located in the chromosome of A. baumannii strains and on a plasmid in non-A. baumannii strains. A resistance gene island carrying blaPER-7 and other resistance determinants was found on a plasmid in some A. baumannii strains.




surveillance

Molecular and Clinical Characterization of Multidrug-Resistant and Hypervirulent Klebsiella pneumoniae Strains from Liver Abscess in Taiwan [Epidemiology and Surveillance]

Hypervirulent Klebsiella pneumoniae strains are the major cause of liver abscesses throughout East Asia, and these strains are usually antibiotic susceptible. Recently, multidrug-resistant and hypervirulent (MDR-HV) K. pneumoniae strains have emerged due to hypervirulent strains acquiring antimicrobial resistance determinants or the transfer of a virulence plasmid into a classic MDR strain. In this study, we characterized the clinical and microbiological properties of K. pneumoniae liver abscess (KPLA) caused by MDR-HV strains in Taiwan. Patients with community onset KPLA were retrospectively identified at Taipei Veterans General Hospital during January 2013 to May 2018. Antimicrobial resistance mechanisms, capsular types, and sequence types were determined. MDR-HV strains and their parental antimicrobial-susceptible strains further underwent whole-genome sequencing (WGS) and in vivo mice lethality tests. Thirteen MDR-HV strains were identified from a total of 218 KPLA episodes. MDR-HV strains resulted in similar outcomes to antimicrobial-susceptible strains. All MDR-HV strains were traditional hypervirulent clones carrying virulence capsular types. The major resistance mechanisms were the overexpression of efflux pumps and/or the acquisition of ESBL or AmpC β-lactamase genes. WGS revealed that two hypervirulent strains had evolved to an MDR phenotype due to mutation in the ramR gene and the acquisition of an SHV-12-bearing plasmid, respectively. Both these MDR-HV strains retained high virulence compared to their parental strains. The spread of MDR-HV K. pneumoniae strains in the community raises significant public concerns, and measures should be taken to prevent the further acquisition of carbapenemase and other resistance genes among these strains in order to avoid the occurrence of untreatable KPLA.




surveillance

Complications of Endovascular Treatments for Brain Arteriovenous Malformations: A Nationwide Surveillance [INTERVENTIONAL]

BACKGROUND AND PURPOSE:

Embolization is widely performed to treat brain arteriovenous malformations, but little has been reported on factors contributing to complications. We retrospectively reviewed a nationwide surveillance to identify risk factors contributing to complications and short-term clinical outcomes in the endovascular treatment of brain arteriovenous malformations.

MATERIALS AND METHODS:

Data for endovascular treatment of brain arteriovenous malformations were extracted from the Japanese nationwide surveillance. Patient characteristics, brain arteriovenous malformation features, procedures, angiographic results, complications, and clinical outcomes at 30 days postprocedure were analyzed.

RESULTS:

A total of 1042 endovascular procedures (788 patients; mean, 1.43 ± 0.85 procedures per patient) performed in 111 institutions from 2010 to 2014 were reviewed. Liquid materials were used in 976 procedures (93.7%): to perform presurgical embolization in 638 procedures (61.2%), preradiosurgical embolization in 160 (15.4%), and as sole endovascular treatment in 231 (22.2%). Complete or near-complete obliteration of brain arteriovenous malformations was obtained in 386 procedures (37.0%). Procedure-related complications occurred in 136 procedures (13.1%), including hemorrhagic complications in 59 (5.7%) and ischemic complications in 57 (5.5%). Univariate analysis identified deep venous drainage, associated aneurysms, infratentorial location, and preradiosurgical embolization as statistically significant risk factors for complications. Multivariate analysis showed that embolization of brain arteriovenous malformations in the infratentorial location was significantly associated with complications. Patients with complications due to endovascular procedures had worse clinical outcomes 30 days after the procedures than those without complications.

CONCLUSIONS:

Complications arising after endovascular treatment of brain arteriovenous malformations are not negligible even though they may play a role in adjunctive therapy, especially in the management of infratentorial brain arteriovenous malformations.




surveillance

China is using mass surveillance tech to fight new coronavirus spread

QR codes, tracking apps and drones at toll booths are just some of the tech tools China is deploying to monitor the spread of the new coronavirus




surveillance

WeChat's surveillance of international users boosts censorship in China, researchers say

WeChat is one of the world’s most popular apps, but researchers at the University of Toronto caution it is surveilling international users and using their information to broaden censorship on the app in China.



  • News/Technology & Science

surveillance

E&amp;C Leaders Announce Committee Teleconference Forum on COVID-19 Testing, Contact Tracing and Surveillance on May 8

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) today announced that the Full Committee will hold a teleconference forum on Friday, May 8, at 12 pm (EDT) on COVID-19 testing, contact tracing and surveillance. “Our nation cannot effectively combat this terrible pandemic in the weeks and months ahead without significant testing, contact tracing and surveillance,” Pallone and Walden said.  “We look forward to hearing from health experts about what actions they believe are necessary to ensure our communities have the resources they need to fight this pandemic and to confidently reopen their local economies.” During the forum, the Committee will hear from three health experts:  Andy Slavitt, former Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) from 2015-2017.  Mark McClellan, M.D., Ph.D., former Administrator of CMS from 2004-2006 and former Commissioner of the Food and Drug Administration (FDA) from 2002-2004.  Avik Roy,Co-founder and President of the Foundation for Research on Equal Opportunity. This forum is open to the press.  Credentialed reporters interested in listening to the forum live should RSVP to cj.young@mail.house.gov by 4 pm today, Thursday, May 7. ###




surveillance

Joint Statement by Attorney General Eric Holder and Director of National Intelligence James Clapper on the Declassification of Additional Documents Regarding Collection Under Section 501 of the Foreign Intelligence Surveillance Act

Attorney General Eric Holder and Director of National Intelligence James Clapper released the following joint statement Wednesday.



  • OPA Press Releases

surveillance

Department of Justice and the Office of the Director of National Intelligence Announce the Publication of Additional Foreign Intelligence Surveillance Court Filings, Opinions and Orders Regarding Collection Under Section 501 of the Foreign Intelligence Su

On January 3, 2014, the Director of National Intelligence declassified and disclosed publically that the U.S. government had filed an application with the Foreign Intelligence Surveillance Court seeking renewal of the authority to collect telephony metadata in bulk, and that, the FISC renewed that authority. The Office of the Director National Intelligence also announced that the Administration was undertaking a declassification review of the FISC's January 3 primary order. On February 12, 2014, and following a declassification review by the Executive Branch, the FISC released in redacted form the previously classified January 3 primary order it had issued in Docket Number BR 14-01, along with a number of other documents.



  • OPA Press Releases

surveillance

Joint Statement from the Office of the Director of National Intelligence and the Department of Justice on the Declassification of Renewal of Collection Under Section 501 of the Foreign Intelligence Surveillance Act

The Justice Department and the Office of the Director of National Intelligence released the following joint statement Friday



  • OPA Press Releases

surveillance

Department of Justice and Office of the Director of National Intelligence Announce Declassification of Renewal of Collection Under Section 501 of the Foreign Intelligence Surveillance Act

The Department of Justice and the Office of the Director of National Intelligence (DNI) released the following statement Friday



  • OPA Press Releases

surveillance

African-American men with low-risk prostate cancer treated with radical prostatectomy in an equal-access health care system: implications for active surveillance




surveillance

Correction: Importance of gastric cancer for the diagnosis and surveillance of Japanese Lynch syndrome patients




surveillance

How surveillance technology powered South Korea’s COVID-19 response

South Korea has been widely praised for its use of technology in containing the coronavirus, and that praise has, at times, generated a sense of mystique, suggesting that Korea has developed sophisticated new tools for tracing and stopping the outbreak. But the truth is far simpler. The tools deployed by Korean authorities are readily available…

       




surveillance

Missed Connections: Talking With Europe About Data, Privacy, and Surveillance


The United States exports digital goods worth hundreds of billions of dollars across the Atlantic each year.  And both Silicon Valley and Hollywood do big business with Europe every year.  Differences in approaches to privacy have always made this relationship unsteady but the Snowden disclosures greatly complicated the prospects of a Transatlantic Trade and Investment Partnership.  In this paper Cameron Kerry examines that politics of transatlantic trade and the critical role that U.S. privacy policy plays in these conversations.

Kerry relies on his experience as the U.S.’s chief international negotiator for privacy and data regulation to provide an overview of key proposals related to privacy and data in Europe.  He addresses the possible development of a European Internet and the current regulatory regime known as Safe Harbor. Kerry argues that America and Europe have different approaches to protecting privacy both which have strengths and weaknesses.

To promote transatlantic trade the United states should:

  • Not be defensive about its protection of privacy
  • Provide clear information to the worldwide community about American law enforcement surveillance
  • Strengthen its own privacy protection
  • Focus on the importance of trade to the American and European economies

Downloads

Image Source: © Francois Lenoir / Reuters
      
 
 




surveillance

Threats to the Future of Cloud Computing: Surveillance and Transatlantic Trade


The first instance of “cloud” computing came in 2006, when Amazon released its Elastic Compute Cloud, a service for consumers to lease space on virtual machines to run software. Now, the cloud enables the transfer and storage of data around the world, in an almost seamless fashion. Using cloud services are a seamless experience from the consumer perspective. This ease of use obscures significant regulation from governments on both sides of the Atlantic. The Safe Harbor Principles is a framework that ensures that personal consumer data being transferred from the EU to the US is still subject to a level of security in compliance with the EU’s stricter regulation on data protection. US companies must be certified within this framework, in order to transfer consumer data outside the EU.

A comprehensive data privacy arrangement that satisfies both sides of the Atlantic is necessary to preserve the free flow of data, and the resulting commerce, between the two regions. Speaking at the 2014 Cloud Computing Policy Conference, Cameron F. Kerry suggested that neither side of the Atlantic can afford to partition the Internet. Currently trade negotiators are assessing the viability including an update to Safe Harbor Principles as a part of the Transatlantic Trade and Investment Partnership (TTIP).

TTIP and the Future of Trade

The NSA revelations last year have only increased support for further regulation over the transfer of personal data in the cloud, especially in the European Union (EU). The revelations have also brought to light significant differences in the European and US conceptions of privacy. The ruling by the European Court of Justice on the “right to be forgotten” is a recent example of this transatlantic divide. In EU countries, citizens can now request Google to take down links from search results that lead users to potentially damaging information.

There are several disputes that negotiators must first resolve. Europeans would prefer that American regulators take a more active role in cases where US firms are violating the Safe Harbor principles. EU officials have also indicated they would like to include a mechanism to send an alert if data were improperly shared with US law enforcement officials. The expansion of the codes of conduct within the cloud would serve as a major step towards finalizing TTIP. A European Commission Analysis finds that TTIP would inject about $130 billion into the US economy. Ultimately both the EU and the US have so much to gain that both nations must find a way to resolve these thorny issues.

 

Kevin Risser contributed to this post.

Authors

Image Source: © Fabrizio Bensch / Reuters
      
 
 




surveillance

How surveillance technology powered South Korea’s COVID-19 response

South Korea has been widely praised for its use of technology in containing the coronavirus, and that praise has, at times, generated a sense of mystique, suggesting that Korea has developed sophisticated new tools for tracing and stopping the outbreak. But the truth is far simpler. The tools deployed by Korean authorities are readily available…

       




surveillance

Managing health privacy and bias in COVID-19 public surveillance

Most Americans are currently under a stay-at-home order to mitigate the spread of the novel coronavirus, or COVID-19. But in a matter of days and weeks, some U.S. governors will decide if residents can return to their workplaces, churches, beaches, commercial shopping centers, and other areas deemed non-essential over the last few months. Re-opening states…

       




surveillance

Engaging patients: Building trust and support for safety surveillance


Event Information

June 23, 2015
9:00 AM - 3:00 PM EDT

Washington Plaza Hotel
10 Thomas Circle, NW
Washington, DC 20005

The Sentinel System is a state of the art active surveillance system relying on a distributed data network to rapidly scale analysis of health care data collected from over 178 million patients nationwide. Sentinel is an important safety surveillance tool used by the U.S. Food and Drug Administration (FDA), and its underlying distributed data infrastructure is increasingly being recognized to have the potential to support the needs of diverse stakeholders including other public health agencies, health systems, regulated industry, and the clinical research enterprise. Despite Sentinel’s importance in safety surveillance, patients are largely unaware of Sentinel’s public health mission and commitment to protecting patient privacy. Therefore, it is both timely and critical to identify opportunities to raise awareness and build trust for Sentinel safety surveillance among patients, consumers, and the general public.

On June 23, the Center for Health Policy at Brookings, in collaboration with the FDA, hosted an expert workshop to discuss opportunities to raise awareness of the Sentinel System through improved communication to patients and consumers. Participants, including Sentinel Data Partners, patient focused organizations (e.g., consumer advocacy groups), experts in patient privacy, ethics, and health literacy, and representatives from the FDA explored possible opportunities where each stakeholder might be uniquely positioned to engage with patients, and how these communications could be designed and delivered effectively. Discussions from this workshop resulted in recommendations including a set of guiding principles, potential tools, and strategies to improve awareness of the Sentinel System, but more broadly, safety surveillance activities led by the FDA.

Event Materials

       




surveillance

Drones and Aerial Surveillance: Considerations for Legislators


     
 
 




surveillance

Drones and Aerial Surveillance: The Opportunities and The Risks


Businesses, citizens, and law enforcement officials are discovering innovative new uses for drones every day. Drones have a distinctively menacing reputation because TV footage typically depicts them flying over a faraway battlefield launching missiles. In the popular imagination, drones have replaced the black helicopters of the 1990s and the satellite images of the 2000s as the primary surveillance tool. For this reason many perceive the drone as a threat to civil rights and safety in the United States. Privacy advocates have called upon lawmakers to pass legislation that keeps drones out of American skies. Others see a potentially beneficial role from drones if effective regulations are developed. In a recent paper titled Drones and Aerial Surveillance: Considerations For Legislators, Gregory McNeal proposes a model for how Congress should regulate drones.

McNeal’s Policy Recommendations

Privacy advocates have argued that law enforcement officers should secure a warrant before ever using a drone for surveillance. McNeal contends that the best standard relies on an interpretation of property rights law with a few supplementary criteria:

  1. Property Rights: As mentioned above, landowners should be allowed to deny aircraft access to a column of airspace extending from their property for up to 350ft.
  2. Duration-Based Surveillance: Law enforcement officials should only be able to survey an individual using a drone for a specific amount of time.
  3. Data Retention: Data collected from a drone on a surveillance flight should only be accessible to law enforcement officials for a period of time. The data would eventually be deleted when there is no longer a level of suspicion associated with the monitored individual.
  4. Transparency: Government agencies should be required to regularly publish information about the use of aerial surveillance equipment.

Expectation of Privacy

The crucial factors in determining whether the 4th Amendment prohibits drone monitoring has to do with the surveyed individuals’ expectation of privacy. In California vs. Ciraolo a police officer received a tip that a man was growing marijuana in a walled off part of his yard not visible from the street. The officer obtained a private aircraft and flew at an altitude of 1,000 feet in order to survey the walled off space. The Supreme Court ultimately ruled this type of “naked-eye” surveillance was not unlawful because it was within what the Federal Aviation Administration (FAA) calls a publicly navigable airspace. The officer had the right to view the walled off portion of the yard because it could be viewed in public airspace.

McNeal cites the expectation of privacy as a central point of his argument against the advocates who don’t want any drones in the air. He asserts that his approach actually offers more protections for privacy as opposed to a warrant requirement approach. He argues that it is not reasonable to expect privacy in a public place. For example there is no functional difference between a police officer monitoring a public protest and a drone monitoring one. McNeal wisely argues that it is possible to live in a world where a person’s privacy is respected and drones can be utilized to help create a safer society.

Matt Mariano contributed to this post.

Authors

  • Joshua Bleiberg
Image Source: © Mike Segar / Reuters
     
 
 




surveillance

The State of Drug Safety Surveillance in the U.S.: Much Improved, More to Come


When a new drug is approved in the United States, it is virtually impossible to know all of the risks that a population may encounter when using that product. Even though the U.S. Food and Drug Administration (FDA) requires drug manufacturers to meet rigorous standards demonstrating the drug’s safety and effectiveness for its intended use, once approved, drugs can be used by many more patients than were studied in clinical trials. This may include patients with unique clinical conditions, differing health status, ethnicity, age, or other characteristics which were not well-represented before the drug’s approval. Further, the drugs themselves can be used in different ways and in different settings than were studied. Until recently, FDA did not have the necessary tools and data access to rapidly and consistently track the risks of serious side effects of regulated drugs after approval. Recognizing this challenge, FDA has developed a pilot system to make the best use of available electronic health data using a new data and research network capable of evaluating the safety of medical products in the U.S. 

Authorized by the Food and Drug Administration Amendments Act (FDAAA) of 2007, this pilot is known as Mini-Sentinel, and is part of FDA’s larger Sentinel Initiative. Sentinel was envisioned as a national electronic system to track the safety of regulated medical products, through the use of existing health insurance claims and electronic clinical data that are generated as part of routine care. In the four years since its inception, Mini-Sentinel has made tremendous progress toward developing this system. Mini-Sentinel is comprised of insurance claims and clinical data from 18 participating data-partners, including some of the largest private health plans in the United States. In order to best protect patient privacy, the data from each partner is maintained behind each individual health plan fire-wall. This “distributed data” approach allows a single coordinating center to distribute FDA safety questions in the form of “queries,” to each of the participating data partners to be run against their own data. Aggregated summary results are then sent back to the coordinating center for final analysis. This process allows FDA to access data that can help in addressing safety questions in near real-time.  

Through Mini-Sentinel, FDA has the capability to better understand the safety outcomes using electronic health care data of approximately 169 million covered lives. This accumulation of data represents the capture of 382 million person-years of observation time and billions of prescription dispensings.[1] Examples of the types of safety questions that have already been addressed by Mini-Sentinel include the following:

  • Safety concerns with drugs used to treat high blood pressure and the incidence of angioedema;
  • Safety concerns with a new diabetes treatment and the incidence of heart attacks; and
  • Impact of FDA regulatory actions (i.e. drug label changes) intended to mitigate serious risks of drugs.

The Mini-Sentinel pilot has demonstrated substantial progress and has proven to be a very useful tool for FDA, largely due to the strong partnerships developed between FDA, collaborating academic institutions, and private health plans. However, in order to ensure continued progress and long-term sustainability, it will be critical for progress to continue in several key areas. 

First, continued methods development and data understanding will be necessary to ensure FDA has access to the most innovative tools. The field of pharmacoepidemiology and drug safety surveillance is still young and the continued development of better study designs and analytic tools to quantify risks of serious adverse events, while accounting for many confounding factors that are inherent on observational data, will be critical. Further, as health reforms impact that way health care is delivered and financed (e.g., development of accountable care organizations and increased use of bundled payments), the electronic health data will change. It will be important to focus efforts on understanding how these changes will impact data used for safety evaluations. 

Second, it is clear that Sentinel’s contributions may extend well beyond FDA’s medical product assessments. The tools and infrastructure that have been developed by FDA over the last four years could be used as a platform to establish a national resource for a more evidence-based learning health care system. This system will enable a better understanding of not only the risks, but also benefits and best uses, of drugs in the post-market settings. 

FDA has initiated steps to ensure the long-term sustainability and impact of Sentinel infrastructure and tools. Within the next few years, FDA has proposed that Sentinel be transitioned into three main components: the Sentinel Operations Center, the Nation Resource Data Infrastructure, and the Methodological Resource for Medical Product Surveillance using Electronic Healthcare Databases. FDA has indicated that while the Sentinel Operations Center will continue to serve as FDA’s portal to the distributed database, the Nation Resource Data Infrastructure could potentially be used by other groups to support broader evidence generation. Potential groups with interest in improving our understanding of the impact of medical products and who could benefit from this framework include the National Institutes of Health, the Regan-Udall Foundation, the Patient Centered Outcomes Research Institute, and other possible stakeholder groups, such as the private industry. 

Collectively, these components will ensure that FDA continues to have the tools to engage in medical product surveillance, while ensuring the long-term sustainability of the system. In just four years, the Sentinel Initiative has laid the groundwork to transform how FDA, and the nation, benefits from electronic health care data. This network continues to foster a community of stakeholders committed the evidence generation, which will ultimately contribute to a learning health care system.

New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System

For more information on these issues, including discussion by leaders from Sentinel stakeholders, please visit the Sentinel Initiative Public Workshop event page. There you will find archived video, presentations, and further reading.



[1] http://mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx

Video

Authors

      
 
 




surveillance

Dealing with demand for China’s global surveillance exports

Executive summary Countries and cities worldwide now employ public security and surveillance technology platforms from the People’s Republic of China (PRC). The drivers of this trend are complex, stemming from expansion of China’s geopolitical interests, increasing market power of its technology companies, and conditions in recipient states that make Chinese technology an attractive choice despite…

       




surveillance

Dealing with demand for China’s global surveillance exports

Executive summary Countries and cities worldwide now employ public security and surveillance technology platforms from the People’s Republic of China (PRC). The drivers of this trend are complex, stemming from expansion of China’s geopolitical interests, increasing market power of its technology companies, and conditions in recipient states that make Chinese technology an attractive choice despite…

       




surveillance

Applicability of Additional Surveillance Measure (ASM)




surveillance

Applicability of Short Term Additional Surveillance Measure (ST-ASM)




surveillance

Applicability of Additional Surveillance Measure (ASM)




surveillance

Applicability of Short Term Additional Surveillance Measure (ST-ASM)




surveillance

Applicability of Additional Surveillance Measure (ASM)




surveillance

Applicability of Short Term Additional Surveillance Measure (ST-ASM)




surveillance

Graded Surveillance Measure (GSM) - Periodic relaxation of Surveillance action




surveillance

New tax and expenditure elasticity estimates for EU budget surveillance

This paper estimates the elasticities of government revenue and expenditure items with respect to the output gap for European Union (EU) countries. These elasticities are used by the European Commission, as part of the EU fiscal surveillance process, to calculate the semi-elasticity of the budget balance as a percentage of GDP with respect to the output gap.




surveillance

China’s Covid-19 QR code surveillance state

Phone-based system controls entry and exit to neighbourhoods and taxi cabs




surveillance

'Rand Paul v. Barack Obama' lawsuit hits federal court with 350,000 plaintiffs, as U.S. senator sues White House and intelligence chiefs over NSA surveillance

The Libertarian firebrand has his eyes focused on the presidency and aims to organize voters by branding NSA snooping as 'precisely the kind of overreach we fought a revolution over.'




surveillance

'What's he waiting for?': Rand Paul says Obama should end the NSA's mass surveillance program through an executive order if he's so against it

The president's spokesman said this afternoon that the Obama does not have the ability to alter the program with a swish of his pen as Paul demanded.




surveillance

Surveillance video shows female burglar take a painful tumble from ceiling

Officials in Ventura County, Florida, have released surveillance video showing a female burglar falling through the ceiling of an Ojai restaurant during a break-in on Halloween morning.




surveillance

Bombshell messages reveal how Donald Trump ally had ambassador to Ukraine put under surveillance

The House Intelligence panel released documents from Giuliani associate Lev Parnas including messages about the physical location of a U.S. ambassador by a GOP congressional candidate.




surveillance

Coronavirus Russia: Putin launches hi-tech surveillance and AI

President Vladimir Putin said the spread of coronavirus in Russia is  'under control' today, after touring a new facility built to spot empty supermarket shelves and to track quarantined citizens.




surveillance

Harry Styles keeps his performance looks under 24-hour surveillance in 'cryogenically frozen' vault

His go-to designer Harris Reed recently revealed that the Sweet Creature artist keeps his costumes under 24-hour surveillance in a vault.




surveillance

Chilling surveillance video shows two gym friends leaving bar before fatal shooting

Surveillance video from World of Beer bar in Coconut Creek, Florida, shows murder suspect Yvonne Serrano, 51, leaving with victim Daniela Maya, 21, early Saturday, hours before her death.




surveillance

Coronavirus location data could pave the way for greater public surveillance

An increased use of phone location data by local authorities to track the spread of COVID-19 or observe social distancing could lead to greater public surveillance after the pandemic.




surveillance

Countries must return to public health surveillance in COVID-19 fight -WHO

Countries must return to "basic principles" of public health surveillance if they are to bring the coronavirus outbreak under control, the World Health Organization's (WHO) top emergency health expert Mike Ryan said on Friday (May 8).




surveillance

Countries must return to public health surveillance in COVID-19 fight -WHO

Countries must return to "basic principles" of public health surveillance if they are to bring the coronavirus outbreak under control, the World Health Organization's (WHO) top emergency health expert Mike Ryan said on Friday (May 8).




surveillance

Police are increasingly using social media surveillance tools

This summer, the American Civil Liberties Union of California requested records from 63 police departments, sheriffs and district attorneys across California. Of the records they received, 40 percent of the agencies (20) used social media surveillance tools, and most of them started using them within the last year.

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