The proliferated use of medical algorithms in health care has brought about medical innovation and improvements; however, there is a cost to a prevalent use of artificial intelligence in health care—exacerbating racism in the medicine. This Article examines the use of race in medical algorithms. Part II describes the development of medical AI, including its advantages and disadvantages. Part III focuses on how the use of medical algorithms may embed racism into our health care system. Part IV describes the FDA’s current regulations on medical AI. The Article concludes by advocating for legislation and regulations that work to reduce racial bias in medical algorithms.
{"title":"The Use of Race in Medical Artificial Intelligence","authors":"Priya Desai","doi":"10.5195/TLP.2021.253","DOIUrl":"https://doi.org/10.5195/TLP.2021.253","url":null,"abstract":"The proliferated use of medical algorithms in health care has brought about medical innovation and improvements; however, there is a cost to a prevalent use of artificial intelligence in health care—exacerbating racism in the medicine. This Article examines the use of race in medical algorithms. Part II describes the development of medical AI, including its advantages and disadvantages. Part III focuses on how the use of medical algorithms may embed racism into our health care system. Part IV describes the FDA’s current regulations on medical AI. The Article concludes by advocating for legislation and regulations that work to reduce racial bias in medical algorithms.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132853113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Soaring drug prices are one of the greatest challenges facing the American healthcare system today. Major contributing factors include the extended use of market exclusivity granted by the FDA and the abuse of the Orphan Drug Act beyond its original purpose. This Note will discuss the regulatory and legislative history of the FDA from its inception to its current state and use a comprehensive analysis of monoclonal antibodies to highlight the practical effects high drug prices have on patient care. Finally, this Note will provide recommendations to shift the regulatory and legislative approach surrounding the FDA away from favoring innovation to supporting competition in the drug market, thus improving accessibility.
{"title":"For Profit or For Health? It is Time to Reckon With the Current Pharmaceutical Landscape Through a Systematic Analysis of Monoclonal Anitbodies","authors":"Alexander Snyder","doi":"10.5195/TLP.2021.251","DOIUrl":"https://doi.org/10.5195/TLP.2021.251","url":null,"abstract":"Soaring drug prices are one of the greatest challenges facing the American healthcare system today. Major contributing factors include the extended use of market exclusivity granted by the FDA and the abuse of the Orphan Drug Act beyond its original purpose. This Note will discuss the regulatory and legislative history of the FDA from its inception to its current state and use a comprehensive analysis of monoclonal antibodies to highlight the practical effects high drug prices have on patient care. Finally, this Note will provide recommendations to shift the regulatory and legislative approach surrounding the FDA away from favoring innovation to supporting competition in the drug market, thus improving accessibility.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124063764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Per- and polyfluoroalkyl, more commonly known as PFAS, has been found in the blood of 95% of the population. PFAS is a family of over 3,000 human-made chemicals. One chemical in the PFAS family, PFOA, is most well-known for its use in Teflon products and has been the subject of multiple litigations. While PFOA has been phased out of production in the United States due to its known negative human health effects, other PFAS that are just as harmful are now used in place of PFOA. The molecular structure of PFAS contains strong bonds that are difficult to break down through natural processes. This characteristic makes PFAS both extremely helpful to industrial processes and harmful to human health and the environment. Because of its resiliency, PFAS remain in the environment long after initial release. Its stability and endurance have led scientists to dub PFAS as “the forever chemical.” This Note explores the history of PFAS production in the United States and concludes with potential regulatory action that can be taken to limit human exposure to PFAS.
{"title":"Me-FAS, You-FAS, We All Eat PFAS: What To Do About the Forever Chemical","authors":"N. Johnson","doi":"10.5195/TLP.2021.247","DOIUrl":"https://doi.org/10.5195/TLP.2021.247","url":null,"abstract":"Per- and polyfluoroalkyl, more commonly known as PFAS, has been found in the blood of 95% of the population. PFAS is a family of over 3,000 human-made chemicals. One chemical in the PFAS family, PFOA, is most well-known for its use in Teflon products and has been the subject of multiple litigations. While PFOA has been phased out of production in the United States due to its known negative human health effects, other PFAS that are just as harmful are now used in place of PFOA. The molecular structure of PFAS contains strong bonds that are difficult to break down through natural processes. This characteristic makes PFAS both extremely helpful to industrial processes and harmful to human health and the environment. Because of its resiliency, PFAS remain in the environment long after initial release. Its stability and endurance have led scientists to dub PFAS as “the forever chemical.” This Note explores the history of PFAS production in the United States and concludes with potential regulatory action that can be taken to limit human exposure to PFAS.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130311803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The world was fundamentally changed by the rampant spread of COVID-19 in 2020. This is not the first and will not be the last time the world is faced with a pandemic. Thus, it is essential to take the necessary steps now to be prepared in the future. This Note will address how patent law can protect inventions incorporating the biomedical data to prevent future pandemics. The Note compares U.S. and European Patent Regimes to determine which system is better at protecting biomedical data. Lastly, this Note proposes changes to the U.S. Patent Regime to help increase its compatibility with biomedical data.
{"title":"Patent Eligibility: Exploring the Intersection Between Patent Law and Biomedical Data","authors":"Erin A. Napoleon","doi":"10.5195/TLP.2021.246","DOIUrl":"https://doi.org/10.5195/TLP.2021.246","url":null,"abstract":"The world was fundamentally changed by the rampant spread of COVID-19 in 2020. This is not the first and will not be the last time the world is faced with a pandemic. Thus, it is essential to take the necessary steps now to be prepared in the future. This Note will address how patent law can protect inventions incorporating the biomedical data to prevent future pandemics. The Note compares U.S. and European Patent Regimes to determine which system is better at protecting biomedical data. Lastly, this Note proposes changes to the U.S. Patent Regime to help increase its compatibility with biomedical data.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114792002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Smartwatches like Fitbits provide users with easy access to quantifiable health data. In the sports industry, tracking this biometric information may be particularly beneficial to athletes, whose livelihoods revolve around their health and fitness. Nonetheless, under the current regime, professional and collegiate athletes’ biometric health data are inadequately protected. Data privacy law is still in its infancy, but in the meantime, athletes must consider that motivations to sell or misuse players’ biometric information may outpace legal developments. This Paper will analyze the promise and risk of collecting professional and collegiate athletes’ health and biometric data, particularly through fitness wearables. It will provide a closer look at wearables in professional sports and consider the increased risk posed to college athletes. Finally, this Paper will consider possible solutions to maximize the benefits of newfound technology while simultaneously minimizing risks to players’ health information, privacy, and personal data ownership.
{"title":"Biometric Monitoring Devices: Modern Solutions to Protecting Athletes’ Data Privacy","authors":"Tristan A. Dietrick","doi":"10.5195/TLP.2021.245","DOIUrl":"https://doi.org/10.5195/TLP.2021.245","url":null,"abstract":"Smartwatches like Fitbits provide users with easy access to quantifiable health data. In the sports industry, tracking this biometric information may be particularly beneficial to athletes, whose livelihoods revolve around their health and fitness. Nonetheless, under the current regime, professional and collegiate athletes’ biometric health data are inadequately protected. Data privacy law is still in its infancy, but in the meantime, athletes must consider that motivations to sell or misuse players’ biometric information may outpace legal developments. This Paper will analyze the promise and risk of collecting professional and collegiate athletes’ health and biometric data, particularly through fitness wearables. It will provide a closer look at wearables in professional sports and consider the increased risk posed to college athletes. Finally, this Paper will consider possible solutions to maximize the benefits of newfound technology while simultaneously minimizing risks to players’ health information, privacy, and personal data ownership.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122004790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Drug bearing nano-shells that can be utilized for targeted drug delivery have been shown to enhance the therapeutic index by increasing the dug concentration in diseased tissue and reducing the toxicity in normal tissue. The controllability of the drug bearing shell size provides predictability measure for the amount of drug payload per shell which improves the administration of the therapeutic dose. The FDA approved different formulations for clinical use in metastatic and recurrent breast cancer, among other diseases. At the moment, some of these formulations are the subject of international clinical trials. Informed consent is legally mandated in administering drug bearing nano-shells. The risks of the new formulations, as with all new technologies, are not well known and are continue to be a subject of intensive research, thus exacerbating the existing informed consent legal issues, thus exacerbating the existing informed consent legal issues. This short essay focuses on proposing a framework to mitigate liabilities administering a new formulation on nano-enabled drug carriers particularly when uncertainties of the benefits and damages are not fully known.
{"title":"Nano-drug Clinical Trials: Informed Consent and Risk Management Through Blockchain","authors":"Y. Haik, I. Bantekas","doi":"10.5195/TLP.2021.243","DOIUrl":"https://doi.org/10.5195/TLP.2021.243","url":null,"abstract":"Drug bearing nano-shells that can be utilized for targeted drug delivery have been shown to enhance the therapeutic index by increasing the dug concentration in diseased tissue and reducing the toxicity in normal tissue. The controllability of the drug bearing shell size provides predictability measure for the amount of drug payload per shell which improves the administration of the therapeutic dose. The FDA approved different formulations for clinical use in metastatic and recurrent breast cancer, among other diseases. At the moment, some of these formulations are the subject of international clinical trials. Informed consent is legally mandated in administering drug bearing nano-shells. The risks of the new formulations, as with all new technologies, are not well known and are continue to be a subject of intensive research, thus exacerbating the existing informed consent legal issues, thus exacerbating the existing informed consent legal issues. This short essay focuses on proposing a framework to mitigate liabilities administering a new formulation on nano-enabled drug carriers particularly when uncertainties of the benefits and damages are not fully known.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131897482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Automotive Industry has registered an impeccable growth rate since the adoption of autonomous vehicles by vehicle manufacturers in their high-end models. These fully autonomous vehicles are poised to replace the traditional human driver. Hence, the whole set of laws defining liability in the event of an accident involving a vehicle have to be reformed. An autonomous vehicle being sued in lieu of a human driver, would be impractical. With the accidents involving autonomous vehicles increasing, newly minted laws like that of Michigan Harbor Lacunas are forming to address the question of liability and as a consequence of which the innocent (the manufacturer in so many cases) is held absolutely liable, despite his pleading defense. Such a harsh stance is unhealthy for the development of technology. Apart from the conundrum surrounding liability there are other dimensions which are equally unaddressed when it comes to automation. These autonomous vehicles rely on data, thereby adding to the vulnerability of protection of an individual’s privacy. These brimming chaos are likely to hamper the aggrandizement of technology and subsequent protection of commercial interests. This Article is an attempt to comprehensively analyze the uncertainty surrounding the questions of liability and privacy protection for autonomous vehicles. It takes into account the technology friendly interpretation of law, which will balance the diametrically opposite variables. It draws the laws from the existing set of principles available. Further, it proposes a new framework eliminate obscurity and concludes on a positive note with recommendations which are likely to accentuate the effectiveness of the current laws and lay down a steppingstone for the future development of laws.
{"title":"The Convolution Addressing the Conundrum of Liability and Privacy in the Age of Autonomous Vehicles","authors":"Aarushi Kapoor, Khushi Sharma","doi":"10.5195/TLP.2021.239","DOIUrl":"https://doi.org/10.5195/TLP.2021.239","url":null,"abstract":"The Automotive Industry has registered an impeccable growth rate since the adoption of autonomous vehicles by vehicle manufacturers in their high-end models. These fully autonomous vehicles are poised to replace the traditional human driver. Hence, the whole set of laws defining liability in the event of an accident involving a vehicle have to be reformed. An autonomous vehicle being sued in lieu of a human driver, would be impractical. With the accidents involving autonomous vehicles increasing, newly minted laws like that of Michigan Harbor Lacunas are forming to address the question of liability and as a consequence of which the innocent (the manufacturer in so many cases) is held absolutely liable, despite his pleading defense. Such a harsh stance is unhealthy for the development of technology. Apart from the conundrum surrounding liability there are other dimensions which are equally unaddressed when it comes to automation. These autonomous vehicles rely on data, thereby adding to the vulnerability of protection of an individual’s privacy. These brimming chaos are likely to hamper the aggrandizement of technology and subsequent protection of commercial interests. This Article is an attempt to comprehensively analyze the uncertainty surrounding the questions of liability and privacy protection for autonomous vehicles. It takes into account the technology friendly interpretation of law, which will balance the diametrically opposite variables. It draws the laws from the existing set of principles available. Further, it proposes a new framework eliminate obscurity and concludes on a positive note with recommendations which are likely to accentuate the effectiveness of the current laws and lay down a steppingstone for the future development of laws.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"185 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123247052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The collection and analysis of individuals data by governments and organizations is an area that lacks overarching protection at the international level, there is potential for an international system monitoring the use of Big Data and providing protections against violations of the right to privacy among other human rights laws. This paper outlines the policy background, then analyzes the use of Big Data through case studies of collection of data on LBTQ+ in Russia, and Uyghur Muslims in China’s Xinjiang province. After establishing the potential for abuses and violations of human rights and the right to privacy through unfettered access to personal data, this paper then considers proposed models to assess and protect human rights in this area, and looks at the potential for the development of an international monitoring system. To take steps towards developing an international legal framework of data protection I argue that the use of international norms to create monitoring bodies, and treaty law between nation-states and also international organizations can be utilized to develop such a framework.
{"title":"Big Data and \"New Surveillance\": Is International Regulation Feasible?","authors":"Leanne Winkels","doi":"10.5195/TLP.2021.240","DOIUrl":"https://doi.org/10.5195/TLP.2021.240","url":null,"abstract":"The collection and analysis of individuals data by governments and organizations is an area that lacks overarching protection at the international level, there is potential for an international system monitoring the use of Big Data and providing protections against violations of the right to privacy among other human rights laws. This paper outlines the policy background, then analyzes the use of Big Data through case studies of collection of data on LBTQ+ in Russia, and Uyghur Muslims in China’s Xinjiang province. After establishing the potential for abuses and violations of human rights and the right to privacy through unfettered access to personal data, this paper then considers proposed models to assess and protect human rights in this area, and looks at the potential for the development of an international monitoring system. To take steps towards developing an international legal framework of data protection I argue that the use of international norms to create monitoring bodies, and treaty law between nation-states and also international organizations can be utilized to develop such a framework.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"43 1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128216361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Americans have felt the impacts of data breaches annually for over a decade. In the past few years, the impact and number of those breaches have increased, compromising millions of Americans’ informational privacy. This Article examines the privacy protections available to Americans and the issues arising from the lack of regulations that specifically protect data privacy. Section I of this Article offers an overview of privacy in American legal history and case law, global regulatory models, and some notable privacy regulations. Section II explores where those regulatory models and the consumer experience are lacking. Section III takes lessons learned from existing privacy regulations and proposes a suggested mitigation for the national data privacy problem. Finally, Section IV provides concluding thoughts.
{"title":"Babyproofing the House Before the Hurricane: Where We are Missing the Mark","authors":"Anokhy Desai","doi":"10.5195/TLP.2021.241","DOIUrl":"https://doi.org/10.5195/TLP.2021.241","url":null,"abstract":"Americans have felt the impacts of data breaches annually for over a decade. In the past few years, the impact and number of those breaches have increased, compromising millions of Americans’ informational privacy. This Article examines the privacy protections available to Americans and the issues arising from the lack of regulations that specifically protect data privacy. Section I of this Article offers an overview of privacy in American legal history and case law, global regulatory models, and some notable privacy regulations. Section II explores where those regulatory models and the consumer experience are lacking. Section III takes lessons learned from existing privacy regulations and proposes a suggested mitigation for the national data privacy problem. Finally, Section IV provides concluding thoughts.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129019232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sunscreen is a staple in melanoma prevention and foreign innovation in formulation and application provide consumers with methods of sun protection. Nevertheless, FDA regulations designed to protect American consumers from ineffective sunscreens often act as a barrier to entry for these innovative, foreign sunscreens from reaching American consumers. This Note will address balancing concerns between consumer protection and promoting product innovation. The Note outlines the history of sunscreen regulation in the United States. Then it discusses the current regulatory framework and what sunscreen filters are currently available to American consumers before providing examples of foreign innovation in sunscreen formulation.
{"title":"Time for Reapplication: A Review of FDA Sunscreen Regulation & Why it Needs an Update","authors":"E. Davidson","doi":"10.5195/tlp.2020.237","DOIUrl":"https://doi.org/10.5195/tlp.2020.237","url":null,"abstract":"Sunscreen is a staple in melanoma prevention and foreign innovation in formulation and application provide consumers with methods of sun protection. Nevertheless, FDA regulations designed to protect American consumers from ineffective sunscreens often act as a barrier to entry for these innovative, foreign sunscreens from reaching American consumers. This Note will address balancing concerns between consumer protection and promoting product innovation. The Note outlines the history of sunscreen regulation in the United States. Then it discusses the current regulatory framework and what sunscreen filters are currently available to American consumers before providing examples of foreign innovation in sunscreen formulation.","PeriodicalId":185385,"journal":{"name":"Pittsburgh Journal of Technology Law & Policy","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116909271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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