Blogs

How can precision medicine and genomics be scaled using IT infrastructure without raising costs or inequities?

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I. Introduction: The Convergence of Precision Medicine, Genomics, and IT Precision Medicine: A Paradigm Shift in Healthcare Precision medicine represents a transformative approach to healthcare in which medical decisions, treatments, and diagnostics are tailored to the individual characteristics of each patient. Unlike the traditional “one-size-fits-all” model, precision medicine considers the genetic profile, lifestyle, environment, and […]

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Will generative AI (e.g., ChatGPT, Sora) replace or augment roles in patient education, diagnostics, and documentation?

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Introduction Emergence of Generative AI in Healthcare In recent years, generative AI has emerged as one of the most transformative technologies in the healthcare industry. Powered by large language models (LLMs) such as OpenAI’s ChatGPT, Google’s Med-PaLM, and other tools like Sora, these systems are capable of producing human-like text, synthesizing information from vast datasets,

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How can wearable and remote patient monitoring data be meaningfully integrated into clinical care?

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1. Understanding the Ecosystem A. What Are Wearables and RPM Devices? Definition of Wearables Wearables are compact, sensor-enabled electronic devices designed to be worn on the body, typically on the wrist, finger, chest, or even integrated into clothing. These devices continuously collect physiological and behavioral data in real-time, allowing individuals and healthcare providers to monitor

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What role should Big Tech (e.g., Google, Amazon, Apple) play in the future of health data and delivery?

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1. Introduction: Why Big Tech in Healthcare? Market Opportunity and Global Demand The healthcare sector represents one of the world’s largest and most resilient industries, with a global value exceeding $10 trillion. Yet, it is also among the least digitized. From hospital systems and insurance to diagnostics and patient engagement, most healthcare processes remain fragmented,

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How Can Digital Health Tools Address Health Equity and Access in Underserved Populations?

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I. Introduction Health equity refers to the attainment of the highest level of health for all people, ensuring that no one is disadvantaged from achieving this potential because of social, economic, environmental, or demographic conditions. In contrast, underserved populations are those who face barriers to accessing timely, affordable, and high-quality healthcare. These groups typically include

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How do we ensure interoperability between Electronic Health Records (EHRs) across platforms and borders?

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1. Introduction to EHR Interoperability Definition and Core ConceptElectronic Health Record (EHR) interoperability refers to the capability of different healthcare information systems, devices, and applications to access, exchange, and cooperatively use data in a coordinated manner within and across organizational boundaries. The core idea is to enable healthcare providers, regardless of the system they use,

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How Can AI and Machine Learning Be Safely and Effectively Integrated into Clinical Decision-Making?

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1. Introduction The Emergence of AI and ML in Healthcare Artificial Intelligence (AI) and Machine Learning (ML) have emerged as transformative forces in the healthcare industry. Their capacity to process large volumes of medical data, identify patterns, and make predictions has opened new possibilities for improving the accuracy, efficiency, and personalization of care. These technologies

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How can manufacturers ensure Clinical Evaluation Reports (CERs) meet the expectations of Notified Bodies (NBs) under EU MDR?

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Understanding Clinical Evaluation Reports (CERs) in EU MDR Definition and Purpose of Clinical Evaluation Reports (CERs) A Clinical Evaluation Report (CER) is a critical technical document required under the European Union Medical Device Regulation (EU MDR 2017/745). It provides a structured presentation of clinical data to demonstrate that a medical device is safe, performs as

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What Are the Real Consequences of EU MDR on Legacy Devices and Patient Care Access?

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1. Understanding the Term “Legacy Devices” Under EU MDR Definition of Legacy Devices under EU MDR Under the European Union Medical Device Regulation (EU MDR 2017/745), “legacy devices” refer to medical devices that were lawfully placed on the market under the previous regulatory frameworks—the Medical Device Directive (MDD 93/42/EEC) or the Active Implantable Medical Devices

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How Are Custom-Made Devices and Niche Markets Being Affected by EU MDR?

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1. Definition & Regulatory Context Definition of Custom-Made Devices (CMDs) Under Article 2(3) of the EU MDR, a custom-made device is defined as any medical device specifically made in accordance with a written prescription provided by a qualified medical professional, indicating the design characteristics and intended use of the device, and intended solely for the

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