Automating FDA Regulation

In the twentieth century, the Food and Drug Administration (“FDA”) rose to prominence as a respected scientific agency. By the middle of the century, it transformed the U.S. medical marketplace from an unregulated haven for dangerous products and false claims to a respected exemplar of public health. More recently, the FDA’s objectivity has increasingly been questioned. Critics argue the agency has become overly political and too accommodating to industry while lowering its standards for safety and efficacy. The FDA’s accelerated pathways for product testing and approval are partly to blame. They require lower-quality evidence, such as surrogate endpoints, and shift the FDA’s focus from premarket clinical trials toward postmarket surveillance, requiring less evidence up front while promising enhanced scrutiny on the back end. To further streamline product testing and approval, the FDA is adopting outputs from computer models, enhanced by artificial intelligence (“AI”), as surrogates for direct evidence of safety and efficacy. This Article analyzes how the FDA uses computer models and simulations to save resources, reduce costs, infer product safety and efficacy, and make regulatory decisions. To test medical products, the FDA assembles cohorts of virtual humans and conducts digital clinical trials. Using molecular modeling, it simulates how substances interact with cellular targets to predict adverse effects and determine how drugs should be regulated. Though legal scholars have commented on the role of AI as a medical product that is regulated by the FDA, they have largely overlooked the role of AI as a medical product regulator. Modeling and simulation could eventually reduce the exposure of volunteers to risks and help protect the public. However, these technologies lower safety and efficacy standards and may erode public trust in the FDA while undermining its transparency, accountability, objectivity, and legitimacy. Bias in computer models and simulations may prioritize efficiency and speed over other values such as maximizing safety, equity, and public health. By analyzing FDA guidance documents and industry and agency simulation standards, this Article offers recommendations for safer and more equitable automation of FDA regulation

Leapfrogging laboratories: the promise and pitfalls of high-tech solutions for antimicrobial resistance surveillance in low-income settings.

The scope and trajectory of today's escalating antimicrobial resistance (AMR) crisis is inadequately captured by existing surveillance systems, particularly those of lower income settings. AMR surveillance systems typically collate data from routine culture and susceptibility testing performed in diagnostic bacteriology laboratories to support healthcare. Limited access to high quality culture and susceptibility testing results in the dearth of AMR surveillance data, typical of many parts of the world where the infectious disease burden and antimicrobial need are high. Culture and susceptibility testing by traditional techniques is also slow, which limits its value in infection management. Here, we outline hurdles to effective resistance surveillance in many low-income settings and encourage an open attitude towards new and evolving technologies that, if adopted, could close resistance surveillance gaps. Emerging advancements in point-of-care testing, laboratory detection of resistance through or without culture, and in data handling, have the potential to generate resistance data from previously unrepresented locales while simultaneously supporting healthcare. Among them are microfluidic, nucleic acid amplification technology and next-generation sequencing approaches. Other low tech or as yet unidentified innovations could also rapidly accelerate AMR surveillance. Parallel advances in data handling further promise to significantly improve AMR surveillance, and new frameworks that can capture, collate and use alternate data formats may need to be developed. We outline the promise and limitations of such technologies, their potential to leapfrog surveillance over currently available, conventional technologies in use today and early steps that health systems could take towards preparing to adopt them

A compact robotic device for upper-limb reaching rehabilitation

This paper presents a compact linear-motion robotic device for upper-extremity reaching rehabilitation. Starting from conceptual design, the paper describes electronic circuit design and program development. The work develops a prototype that provides active and passive rehabilitation training. In active training, subjects actively move their arm with assistive or resistive force from the device to finish predefined displacement and force profiles. In passive training, subjects remain passive while the device moves the limb following the pre-defined displacement profile. Engineering specifications with adequate safety factor are determined and standard electronic and readily available mechanical components are exploited to keep the total cost low

Automated rating of patient and physician emotion in primary care visits

OBJECTIVE: Train machine learning models that automatically predict emotional valence of patient and physician in primary care visits. METHODS: Using transcripts from 353 primary care office visits with 350 patients and 84 physicians (Cook, 2002 [1], Tai-Seale et al., 2015 [2]), we developed two machine learning models (a recurrent neural network with a hierarchical structure and a logistic regression classifier) to recognize the emotional valence (positive, negative, neutral) (Posner et al., 2005 [3]) of each utterance. We examined the agreement of human-generated ratings of emotional valence with machine learning model ratings of emotion. RESULTS: The agreement of emotion ratings from the recurrent neural network model with human ratings was comparable to that of human-human inter-rater agreement. The weighted-average of the correlation coefficients for the recurrent neural network model with human raters was 0.60, and the human rater agreement was also 0.60. CONCLUSIONS: The recurrent neural network model predicted the emotional valence of patients and physicians in primary care visits with similar reliability as human raters. PRACTICE IMPLICATIONS: As the first machine learning-based evaluation of emotion recognition in primary care visit conversations, our work provides valuable baselines for future applications that might help monitor patient emotional signals, supporting physicians in empathic communication, or examining the role of emotion in patient-centered care

Balancing patient control and practical access policy for electronic health records via blockchain technology

Electronic health records (EHRs) have revolutionized the health information technology domain, as patient data can be easily stored and accessed within and among medical institutions. However, in working towards nationwide patient engagement and interoperability goals, recent literature adopts a very patient-centric model---patients own their universal, holistic medical records and control exactly who can access their health data. I contend that this approach is largely impractical for healthcare workflows, where many separate providers require access to health records for care delivery. My work investigates the potential of a blockchain network to balance patient control and provider accessibility with a two-fold approach. First, I conduct a survey investigation to identify patient concerns and determine the level of control patients would like over their health information. Second, I implement a blockchain network prototype to address the spectrum of patient control preferences and automate practical access policy. There are conflicting demands amongst patients and providers for EHR access---privacy versus flexibility. Yet, I find blockchain technology, when manipulated to model access states, automate an organizational role-based access scheme, and provide an immutable history of behavior in the network, to be a very plausible solution for balancing patient desires and provider needs. My approach is, to my knowledge, the first example of blockchain\u27s use for less patient-centric, nudge theory-based EHR access control, an idea that could align access control interests as academics, the government, and the healthcare industry make strides towards interoperable, universal patient records

Internet of robotic things : converging sensing/actuating, hypoconnectivity, artificial intelligence and IoT Platforms

The Internet of Things (IoT) concept is evolving rapidly and influencing newdevelopments in various application domains, such as the Internet of MobileThings (IoMT), Autonomous Internet of Things (A-IoT), Autonomous Systemof Things (ASoT), Internet of Autonomous Things (IoAT), Internetof Things Clouds (IoT-C) and the Internet of Robotic Things (IoRT) etc.that are progressing/advancing by using IoT technology. The IoT influencerepresents new development and deployment challenges in different areassuch as seamless platform integration, context based cognitive network integration,new mobile sensor/actuator network paradigms, things identification(addressing, naming in IoT) and dynamic things discoverability and manyothers. The IoRT represents new convergence challenges and their need to be addressed, in one side the programmability and the communication ofmultiple heterogeneous mobile/autonomous/robotic things for cooperating,their coordination, configuration, exchange of information, security, safetyand protection. Developments in IoT heterogeneous parallel processing/communication and dynamic systems based on parallelism and concurrencyrequire new ideas for integrating the intelligent “devices”, collaborativerobots (COBOTS), into IoT applications. Dynamic maintainability, selfhealing,self-repair of resources, changing resource state, (re-) configurationand context based IoT systems for service implementation and integrationwith IoT network service composition are of paramount importance whennew “cognitive devices” are becoming active participants in IoT applications.This chapter aims to be an overview of the IoRT concept, technologies,architectures and applications and to provide a comprehensive coverage offuture challenges, developments and applications

Health 4.0: Applications, Management, Technologies and Review

The Industry 4.0 Standard (I4S) employs technologies for automation and data exchange through cloud computing, Big Data (BD), Internet of Things (IoT), forms of wireless Internet, 5G technologies, cryptography, the use of semantic database (DB) design, Augmented Reality (AR) and Content-Based Image Retrieval (CBIR). Its healthcare extension is the so-called Health 4.0. This study informs about Health 4.0 and its potential to extend, virtualize and enable new healthcare-related processes (e.g., home care, finitude medicine, and personalized/remotely triggered pharmaceutical treatments) and transform them into services. In the future, these services will be able to virtualize multiple levels of care, connect devices and move to Personalized Medicine (PM). The Health 4.0 Cyber-Physical System (HCPS) contains several types of computers, communications, storage, interfaces, biosensors, and bioactuators. The HCPS paradigm permits observing processes from the real world, as well as monitoring patients before, during and after surgical procedures using biosensors. Besides, HCPSs contain bioactuators that accomplish the intended interventions along with other novel strategies to deploy PM. A biosensor detects some critical outer and inner patient conditions and sends these signals to a Decision-Making Unit (DMU). Mobile devices and wearables are present examples of gadgets containing biosensors. Once the DMU receives signals, they can be compared to the patient’s medical history and, depending on the protocols, a set of measures to handle a given situation will follow. The part responsible for the implementation of the automated mitigation actions are the bioactuators, which can vary from a buzzer to the remote-controlled release of some elements in a capsule inside the patient’s body.             Decentralizing health services is a challenge for the creation of health-related applications. Together, CBIR systems can enable access to information from multimedia and multimodality images, which can aid in patient diagnosis and medical decision-making. Currently, the National Health Service addresses the application of communication tools to patients and medical teams to intensify the transfer of treatments from the hospital to the home, without disruption in outpatient services. HCPS technologies share tools with remote servers, allowing data embedding and BD analysis and permit easy integration of healthcare professionals expertise with intelligent devices.  However, it is undeniable the need for improvements, multidisciplinary discussions, strong laws/protocols, inventories about the impact of novel techniques on patients/caregivers as well as rigorous tests of accuracy until reaching the level of automating any medical care technological initiative