The future of laboratory medicine - A 2014 perspective.

Predicting the future is a difficult task. Not surprisingly, there are many examples and assumptions that have proved to be wrong. This review surveys the many predictions, beginning in 1887, about the future of laboratory medicine and its sub-specialties such as clinical chemistry and molecular pathology. It provides a commentary on the accuracy of the predictions and offers opinions on emerging technologies, economic factors and social developments that may play a role in shaping the future of laboratory medicine

Litigating Medical Device Premarket Classification Decisions for Small Businesses: Have the Courts Given the FDA Too Much Deference? The Case for Taking the Focus Off of Efficacy

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the FDA’s high premarket review standards, several manufacturers have focused on international opportunities that allow them to place their devices into the market faster and at a lower cost. This Comment discusses the statutory history behind FDA premarket review authority arising under the Feed, Drug, and Cosmetics Act, the FDA’s progeny, and the FDA’s development of regulations designed to ensure that devices are deemed safe through product safety and efficacy determinations. In examining FDA regulations, this Comment reviews pertinent court decisions regarding device manufacturers’ challenges of FDA approval determinations based on safety and efficacy standards. This Comment then addresses how premarket regulations have impacted small businesses and outlines approaches the FDA could adopt to ameliorate systemic problems in the current approval process. Finally, this Comment argues that FDA premarket regulations should focus on product safety and shift product efficacy into the postmarket surveillance regulatory system, which could remove significant hurdles that show the device approval process without compromising patient safety

The Next Wave: Federal Regulatory, Intellectual Property, and Tort Liability Considerations for Medical Device Software, 2 J. Marshall Rev. Intell. Prop. L. 259 (2003)

Counsel for the medical software technologist faces an unusually complex, ongoing, high-stakes challenge. Counsel operates in a special field of commercial, legal and regulatory forces: (1) intellectual property laws which govern the expression and protection of commercial rights derived from advances in medical science and technology; (2) existing and proposed contracts/warranty laws that govern technological commercial relationships; (3) negligence, professional liability, and product liability laws that govern the marketing of medical technologies; and, (4) a new body of regulation derived from the power of the federal government to indirectly provide for the safety, effectiveness, privacy, and security of medical technologies offered to the American public. Against that backdrop, the author provides an illustration of the commercialization of a new medical software technology and suggests a general approach to resolving the primary issues facing the medical software technologist

Health Care Costs and the Arc of Innovation

Health care costs continue their inexorable rise, threatening America’s long-term fiscal stability, competitiveness, and standard of living. Over the past half-century, efforts to rein in spending have uniformly failed. In this Article, we explain why, breaking with standard accounts of regulatory and market dysfunction. We point instead to the nexus of economics, mutual empathy, and social expectations that drives medical innovation and locks in low-value technologies. We show how law reflects and reinforces this nexus and how and why health-policy-makers avert their gaze. Next, we propose to circumvent these barriers instead of surmounting them. Rather than targeting today’s excessive spending, we seek to leverage available legal tools to bend the arc of innovation, away from marginally-beneficial technology and toward high-value advances. To this end, we set forth a novel, value-based approach to pricing and patent protection—one that departs sharply from current practice by rewarding innovators in proportion to the therapeutic benefits new tests and treatments yield. Using cancer therapy as an example, we explain how emerging information technology and large troves of electronic clinical data are opening the way to near-real-time assessment of efficacy. We then show how such assessment can power ongoing adjustment of pricing and patent terms. Finally, we offer a blueprint for how laws governing health care payment and intellectual property can be tailored to realize this value-focused vision. For the reasons we lay out, the transformation of incentives we urge will both slow clinical spending growth and greatly enhance the social value that this spending yields

Risk Assessment Framework for Evaluation of Cybersecurity Threats and Vulnerabilities in Medical Devices

Medical devices are vulnerable to cybersecurity exploitation and, while they can provide improvements to clinical care, they can put healthcare organizations and their patients at risk of adverse impacts. Evidence has shown that the proliferation of devices on medical networks present cybersecurity challenges for healthcare organizations due to their lack of built-in cybersecurity controls and the inability for organizations to implement security controls on them. The negative impacts of cybersecurity exploitation in healthcare can include the loss of patient confidentiality, risk to patient safety, negative financial consequences for the organization, and loss of business reputation. Assessing the risk of vulnerabilities and threats to medical devices can inform healthcare organizations toward prioritization of resources to reduce risk most effectively. In this research, we build upon a database-driven approach to risk assessment that is based on the elements of threat, vulnerability, asset, and control (TVA-C). We contribute a novel framework for the cybersecurity risk assessment of medical devices. Using a series of papers, we answer questions related to the risk assessment of networked medical devices. We first conducted a case study empirical analysis that determined the scope of security vulnerabilities in a typical computerized medical environment. We then created a cybersecurity risk framework to identify threats and vulnerabilities to medical devices and produce a quantified risk assessment. These results supported actionable decision making at managerial and operational levels of a typical healthcare organization. Finally, we applied the framework using a data set of medical devices received from a partnering healthcare organization. We compare the assessment results of our framework to a commercial risk assessment vulnerability management system used to analyze the same assets. The study also compares our framework results to the NIST Common Vulnerability Scoring System (CVSS) scores related to identified vulnerabilities reported through the Common Vulnerability and Exposure (CVE) program. As a result of these studies, we recognize several contributions to the area of healthcare cybersecurity. To begin with, we provide the first comprehensive vulnerability assessment of a robotic surgical environment, using a da Vinci surgical robot along with its supporting computing assets. This assessment supports the assertion that networked computer environments are at risk of being compromised in healthcare facilities. Next, our framework, known as MedDevRisk, provides a novel method for risk quantification. In addition, our assessment approach uniquely considers the assets that are of value to a medical organization, going beyond the medical device itself. Finally, our incorporation of risk scenarios into the framework represents a novel approach to medical device risk assessment, which was synthesized from other well-known standards. To our knowledge, our research is the first to apply a quantified assessment framework to the problem area of healthcare cybersecurity and medical networked devices. We would conclude that a reduction in the uncertainty about the riskiness of the cybersecurity status of medical devices can be achieved using this framework

Regulating Artificial Intelligence and machine learning-enabled medical devices in Europe and the United Kingdom

Recent achievements in respect of Artificial Intelligence (AI) open up opportunities for new tools to assist medical diagnosis and care delivery. However, the typical process for the development of AI is through repeated cycles of learning and implementation, something that poses challenges to our existing system of regulating medical devices. Product developers face tensions between the benefits of continuous improvement/deployment of algorithms and keeping products unchanged. The latter more easily facilitates collecting evidence for safety assurance processes but sacrifices optimisation of performance and adaptation to user needs gained through learning-implementation cycles. The challenge is how to balance potential benefits with the need to assure their safety. Governance and assurance processes are needed that can accommodate real-time or near-real-time machine learning. Such an approach is of great importance in healthcare and other fields of application. AI has stimulated an intense process of learning as this new technology embeds in application contexts. The process is not only about the application of AI in the real world but also about the institutional arrangements for its safe and dependable deployment, including regulatory experimentation involving new market pathways, monitoring and surveillance, and sandbox schemes. We review the key themes, challenges and potential solutions raised at two stakeholder workshops and highlight recent attempts to adapt the laws for AI-enabled medical devices (AIeMD) with a special focus on the regulatory proposals in the UK and internationally. The UK regulatory trajectory shows signs of alignment with the US thinking, and yet the European Union model is still the most closely aligned framework.</p

An Agile Quality Management System For Laboratory Developed Tests

ABSTRACT AN AGILE QUALITY MANAGEMENT SYSTEM FOR LABORATORY DEVELOPED TESTS By RITA D’ANGELO MAY 2017 Advisor: Dr. Ratna Babu Chinnan Major: Industrial & Systems Engineering Degree: Doctor of Philosophy Statement of the Problem: We explore the 2014 draft guidance by the FDA entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDT) extended from the medical device industry and discuss how these requirements may be applicable to laboratory medicine. We introduce terms, definitions and provide a call for action for leaders to prepare for the potential adherence to regulatory requirements and explore if compliance was achievable in a laboratory environment to design, develop and validate Laboratory Developed Tests. If not, why not, and what would be the limiting steps. Method: We perform interviews with laboratory professionals to explore their concerns and challenges regarding the FDA draft guidance then translate the results into strategic factors. Based on the feedback, we surveyed laboratory experts in the field of LDT to develop and test strategic factors that would comprise an effective quality management system framework (QMS) to comply with the FDA proposal. We describe the methodology to translate the strategic factors into a design that would transform the existing laboratory structure into a regulatory quality management system. Conclusion: Nine interviewees and 35 survey respondents shared the importance of risk classification, process validation, patient safety and general ambiguity for the development of LDT. We utilize the top supporting statements and associated factors chosen by experts as extremely important for LDT development as the building blocks for implementation of a regulatory QMS framework. The framework includes six phases of implementation: 1) establishment of a leadership support structure, 2) training, 3) pre-assessment of current laboratory processes, 4) adoption of design control, 5) process controls, 6) process validation and the application of an agile Stage Gate technique for test development. Respondents agree that a regulatory agile quality management system is needed in laboratories that develop LDT. Utilizing the strategic factors, we develop a novel approach to LDT design, development and testing that extends the existing laboratory structure with a proven product development methodology technique called agile stage gate hybrid with the assignment of dedicated, accountable cross-functional teams for go/no-go approvals at every step and institute a coordinator position to review, document and expedite LDT development throughout the testing process

FDA Jurisdiction: A Matter of Definitions

This chapter, new in the third edition, concerns how Congress, the Food and Drug Administration, and the courts have treated the definitions of food, drug, cosmetic, device, and human biological product. The scope of FDA\u27s power is delineated almost entirely by the list of product categories over which it has jurisdiction. As the materials in this chapter show, the product definitions are strikingly broad and thus confer jurisdiction over a vast range of goods. Furthermore, the definitions are remarkably plastic, providing FDA with great flexibility to decide whether and how to regulate products. Sometimes FDA has interpreted the definitions expansively, so as to expand its power. On other occasions, the agency has construed the definitions narrowly, so as to avoid taking responsibility for products it does not want to regulate or to minimize the burdensomeness of the requirements it does impose.https://digitalcommons.wcl.american.edu/facsch_bk_contributions/1187/thumbnail.jp

Food and Drug Regulation: Statutory and Regulatory Supplement

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.https://elibrary.law.psu.edu/fac_books/1029/thumbnail.jp

Impact of EU Medical Device Directive on Medical Device Software

Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls