The document discusses mHealth, which refers to mobile health applications and services. It defines mHealth broadly as integrating mobile technologies into patient-centered care. Current trends show increasing federal support and technology adoption driving mHealth growth. Key mHealth applications span personal health management, health promotion, and disease surveillance across the continuum of care. Opportunities exist to engage with and contribute to the expanding field of mHealth to discover new applications and assess effectiveness.
March 19, 2011 presentation at the Annual conference for the Association for Prevention Teaching and Research on opportunities for students to be engaged with mHealth.
The document summarizes the launch of the Center for Consumer Health Informatics Research (CCHIR) at Nova Southeastern University College of Pharmacy. The goals of CCHIR are to conduct research in consumer health informatics, educate students and the public, and provide training and services. Current and planned research studies focus on areas like mobile health, social media, medicines information, and public health informatics. The center aims to advance the use of technology and information to help consumers manage their health.
Helping Your Patients Make Sense of the mHealth MarketplaceKevin Clauson
This document outlines the mobile health (mHealth) marketplace and patient-centric apps. It discusses how apps can enhance patient self-care and medication adherence. It also delineates approaches for guiding patients to mHealth apps and tools. The mHealth app market largely remains "buyer beware" with FDA regulation pending. Current evidence is stronger for texting than apps in improving outcomes, but many studies are underway. mHealth offers opportunities to improve patient engagement, activation, and health.
This document discusses telemedicine and remote patient monitoring in the United States. It provides an overview of the growth and policies around telemedicine in the US. It specifically highlights Teladoc as the largest and first telemedicine company to have an IPO. Teladoc provides virtual visits via internet, phone or video chat and aims to provide care within 10 minutes. It has over 6,000 business customers and 11.5 million members. The document summarizes Teladoc's business model, revenue sources, and recent acquisition of HealthiestYou.
The document discusses mHealth, which refers to mobile health applications and services. It defines mHealth broadly as integrating mobile technologies into patient-centered care. Current trends show increasing federal support and technology adoption driving mHealth growth. Key mHealth applications span personal health management, health promotion, and disease surveillance across the continuum of care. Opportunities exist to engage with and contribute to the expanding field of mHealth to discover new applications and assess effectiveness.
March 19, 2011 presentation at the Annual conference for the Association for Prevention Teaching and Research on opportunities for students to be engaged with mHealth.
The document summarizes the launch of the Center for Consumer Health Informatics Research (CCHIR) at Nova Southeastern University College of Pharmacy. The goals of CCHIR are to conduct research in consumer health informatics, educate students and the public, and provide training and services. Current and planned research studies focus on areas like mobile health, social media, medicines information, and public health informatics. The center aims to advance the use of technology and information to help consumers manage their health.
Helping Your Patients Make Sense of the mHealth MarketplaceKevin Clauson
This document outlines the mobile health (mHealth) marketplace and patient-centric apps. It discusses how apps can enhance patient self-care and medication adherence. It also delineates approaches for guiding patients to mHealth apps and tools. The mHealth app market largely remains "buyer beware" with FDA regulation pending. Current evidence is stronger for texting than apps in improving outcomes, but many studies are underway. mHealth offers opportunities to improve patient engagement, activation, and health.
This document discusses telemedicine and remote patient monitoring in the United States. It provides an overview of the growth and policies around telemedicine in the US. It specifically highlights Teladoc as the largest and first telemedicine company to have an IPO. Teladoc provides virtual visits via internet, phone or video chat and aims to provide care within 10 minutes. It has over 6,000 business customers and 11.5 million members. The document summarizes Teladoc's business model, revenue sources, and recent acquisition of HealthiestYou.
This document discusses mobile health (mHealth) apps for pharmacy use. It defines mHealth and reviews the most useful pharmacy apps, including drug references, calculators, and patient education apps. Key apps mentioned are Epocrates Rx, Lexicomp, MedCalc, and Micromedex. The document also discusses how mHealth apps can help deliver services, engage patients, and extend the pharmacy's role. Images are provided showing various mobile device and app interfaces.
디지털 헬스케어를 어떻게 구현할 것인가: 국내 스타트업 업계를 중심으로Yoon Sup Choi
You're correct. FaceNet, developed by Google, achieved state-of-the-art performance on the Labeled Faces in the Wild (LFW) dataset, with a reported accuracy of 99.63%. This surpasses both the 95% accuracy of earlier systems as well as DeepFace from Facebook, which achieved 97.35% accuracy on LFW. FaceNet demonstrates the rapid progress being made in deep learning for face recognition tasks.
Presentation given to health-care management class discussing how military research impacts medical innovations eventually benefiting the civilian population
This document discusses the use of mobile phones for healthcare and public health initiatives, known as mHealth. It details the 12 main clusters of mHealth applications, including patient communication, access to web-based resources, point-of-care tools, disease management, education, and more. The document examines how widespread mobile phone ownership is globally and among different populations. It argues that mHealth offers opportunities to improve individual and population health as well as address disparities, but that barriers still exist that must be overcome for successful initiatives.
This document discusses emerging trends in the future of health care, including increased personalization and prevention, faster innovations, and new technologies like nanomedicine, regenerative medicine, and medical androids. Population growth and aging, as well as a shift toward consumer-driven health and lifestyle management, will be major drivers of change. New diagnostic tools and personalized treatments enabled by genomics, proteomics, and other converging technologies may help enhance human performance and longevity.
“Mobile Health(mHealth) is the use of mobile and wireless devices, the technology, to provide Health outcomes, Healthcare services and Health research.”
(1) The system segments histopathology images into epithelial and stromal regions and identifies nuclei.
(2) It constructs a rich set of quantitative features describing the relationships between different image objects.
(3) Using the features, a predictive model is built from images of patients with known 5-year survival outcomes. This model can then predict survival probabilities for new unlabeled images.
A short market review and summary on how the pharmaceutical and healthcare sector can use the mobile platform as their new channel of communication towards their target groups: physicians, patients, hospitals, pharmacies, etc
AI systems have potential benefits but also risks in clinical applications. Adversarial attacks can intentionally cause models to make mistakes, and medical data is vulnerable due to limited authentication. Bias in algorithms can negatively impact patient care. Interpretability is important for trust, diagnosis, and safety issues. Frameworks are needed for developing AI with quality, safety, and accountability.
Promise and peril: How artificial intelligence is transforming health careΔρ. Γιώργος K. Κασάπης
AI has enormous potential to improve the quality of health care, enable early diagnosis of diseases, and reduce costs. But if implemented incautiously, AI can exacerbate health disparities, endanger patient privacy, and perpetuate bias. STAT, with support from the Commonwealth Fund, explored these possibilities and pitfalls during the past year and a half, illuminating best practices while identifying concerns and regulatory gaps. This report includes many of the articles we published and summarizes our findings, as well as recommendations we heard from caregivers, health care executives, academic experts, patient advocates, and others.
This presentation contains an introduction to emerging healthcare Technologies. These emerging technologies include Data Analytics, AI, Blockchain, Telehealth, virtual reality, cloud computing, and IOT. The concept of Nanorobots as future medicine is also included in this presentation.
The explosion in the number of applications (apps) designed for the medical and wellness sectors has been noted by many. Recently we have seen increased presence of truly medical apps, in addition to consumer health and wellbeing apps, designed for clinical professionals and patients with medical conditions.
Consumer based mHealth apps typically allow people to do old things in new ways, such as recording health measures digitally rather than on paper. We see this also with medical apps, where increases in the quality and efficiency of existing health care models provide clinical staff with digital tools that replace paper based documentation. In rare and exciting cases we are also seeing mHealth applications that are doing things in entirely new ways to drive real innovation in health care delivery through mobile devices.
The aim of the tutorial is to highlight real world, high impact mobile research that is relevant to the key discipline of Mobile HCI. Thus, the tutorial will be application rather than academically focused. The tutorial will highlight the wide range of mHealth applications available that go far beyond trackers and behavior change tools and encourage researchers to look beyond consumer applications in their research. Four key areas of mHealth applications will be covered including Apps for the HealthyWell, mHealth in Hospitals, Practice and Clinical Apps and Patient Apps and will cover applications for health assessment, treatment and triage, behavior change, chronic illness, mental health, adolescent health, rehabilitation and age care with a focus on the need for rigorous evaluation and efficacy analysis.
Mobile technology can help bridge health systems gaps and improve reproductive, maternal, newborn and child health outcomes. It has the potential to give every family access to information and services, support health workers, and create a more accountable health system. There are now over 137 mHealth projects at Johns Hopkins using mobile tools in various ways, such as providing education and referrals to communities, decision support and monitoring for health workers, and improving data collection and reporting across the health system. Rigorous evaluation is still needed to demonstrate the impact of mHealth on health outcomes and health systems strengthening.
Remote Patient Monitoring System at Mayo ClinicPeachy Essay
The Remote Patient Monitoring (RPM) system at Mayo Clinic allows doctors to monitor patients' health from a distance. It involves collecting biometric data from patients through mobile devices and transmitting it to medical practitioners. Mayo Clinic developed its RPM system to address issues like rising patient admissions, high emergency room visits, and the need to improve access to specialty care. The system is managed by the Center for Connected Care and involves training for medical staff. Strict security and privacy measures protect patient data collected by the RPM system.
In real sense Smartphone is a mobile phone with advanced features and functionality beyond traditional functionalities like making phone calls and sending text messages. The Smartphone are equipped with the capabilities to display photos, play games, play videos, navigation, built-in camera, audio/video playback and recording, send/receive e-mail, built in apps for social web sites and surf the Web, wireless Internet and much more.The penetration of Mobiles is more than 100% in the developed markets and is rapidly gaining acceptance in the developing regions such as Asia-Pacific, Latin America and Africa. The rising exposure to smartphones with technologies such as 4G and 5G networks will further promote the adoption of mobile devices in most sectors,over half of mobile phone users globally will have smartphones in 2018
Mobile devices are enforcing its use in all aspects of life, health care is one major area where mobile device could enhance operations, or improve quality and efficincy. Here is a presentation I gave at HIMSS which may be useful to you if you are considering using mobile device in your health care discpline.
This document provides an overview of drugs, medical devices, clinical trials, healthcare IT, and regulations. It discusses the types and administration of drugs. It describes medical devices and their types. It explains the objectives, design, and types of clinical trials. It discusses the role of IT in clinical trials and healthcare, including clinical trial management systems and electronic health records. It provides information on the healthcare and clinical trial management systems market. Finally, it lists some key regulating bodies and regulations.
mHealth Israel_Digital Health Regulation and the FDALevi Shapiro
Presentation by Bethany Hills, Partner, Mintz Levin: Digital Health Regulation and the FDA. Includes overview of the 21st Century Cures Act, Definition of a medical device, device approval basics, software as a Medical Device (SaMD), FDA Digital Health Activities, mobile medical applications, regulated mobile medical applications, Enforcement discretions of MMA, Clinical Decision Support, 3060 Clarifying Health Software Regulation, Classification Process,
This document discusses mobile health (mHealth) apps for pharmacy use. It defines mHealth and reviews the most useful pharmacy apps, including drug references, calculators, and patient education apps. Key apps mentioned are Epocrates Rx, Lexicomp, MedCalc, and Micromedex. The document also discusses how mHealth apps can help deliver services, engage patients, and extend the pharmacy's role. Images are provided showing various mobile device and app interfaces.
디지털 헬스케어를 어떻게 구현할 것인가: 국내 스타트업 업계를 중심으로Yoon Sup Choi
You're correct. FaceNet, developed by Google, achieved state-of-the-art performance on the Labeled Faces in the Wild (LFW) dataset, with a reported accuracy of 99.63%. This surpasses both the 95% accuracy of earlier systems as well as DeepFace from Facebook, which achieved 97.35% accuracy on LFW. FaceNet demonstrates the rapid progress being made in deep learning for face recognition tasks.
Presentation given to health-care management class discussing how military research impacts medical innovations eventually benefiting the civilian population
This document discusses the use of mobile phones for healthcare and public health initiatives, known as mHealth. It details the 12 main clusters of mHealth applications, including patient communication, access to web-based resources, point-of-care tools, disease management, education, and more. The document examines how widespread mobile phone ownership is globally and among different populations. It argues that mHealth offers opportunities to improve individual and population health as well as address disparities, but that barriers still exist that must be overcome for successful initiatives.
This document discusses emerging trends in the future of health care, including increased personalization and prevention, faster innovations, and new technologies like nanomedicine, regenerative medicine, and medical androids. Population growth and aging, as well as a shift toward consumer-driven health and lifestyle management, will be major drivers of change. New diagnostic tools and personalized treatments enabled by genomics, proteomics, and other converging technologies may help enhance human performance and longevity.
“Mobile Health(mHealth) is the use of mobile and wireless devices, the technology, to provide Health outcomes, Healthcare services and Health research.”
(1) The system segments histopathology images into epithelial and stromal regions and identifies nuclei.
(2) It constructs a rich set of quantitative features describing the relationships between different image objects.
(3) Using the features, a predictive model is built from images of patients with known 5-year survival outcomes. This model can then predict survival probabilities for new unlabeled images.
A short market review and summary on how the pharmaceutical and healthcare sector can use the mobile platform as their new channel of communication towards their target groups: physicians, patients, hospitals, pharmacies, etc
AI systems have potential benefits but also risks in clinical applications. Adversarial attacks can intentionally cause models to make mistakes, and medical data is vulnerable due to limited authentication. Bias in algorithms can negatively impact patient care. Interpretability is important for trust, diagnosis, and safety issues. Frameworks are needed for developing AI with quality, safety, and accountability.
Promise and peril: How artificial intelligence is transforming health careΔρ. Γιώργος K. Κασάπης
AI has enormous potential to improve the quality of health care, enable early diagnosis of diseases, and reduce costs. But if implemented incautiously, AI can exacerbate health disparities, endanger patient privacy, and perpetuate bias. STAT, with support from the Commonwealth Fund, explored these possibilities and pitfalls during the past year and a half, illuminating best practices while identifying concerns and regulatory gaps. This report includes many of the articles we published and summarizes our findings, as well as recommendations we heard from caregivers, health care executives, academic experts, patient advocates, and others.
This presentation contains an introduction to emerging healthcare Technologies. These emerging technologies include Data Analytics, AI, Blockchain, Telehealth, virtual reality, cloud computing, and IOT. The concept of Nanorobots as future medicine is also included in this presentation.
The explosion in the number of applications (apps) designed for the medical and wellness sectors has been noted by many. Recently we have seen increased presence of truly medical apps, in addition to consumer health and wellbeing apps, designed for clinical professionals and patients with medical conditions.
Consumer based mHealth apps typically allow people to do old things in new ways, such as recording health measures digitally rather than on paper. We see this also with medical apps, where increases in the quality and efficiency of existing health care models provide clinical staff with digital tools that replace paper based documentation. In rare and exciting cases we are also seeing mHealth applications that are doing things in entirely new ways to drive real innovation in health care delivery through mobile devices.
The aim of the tutorial is to highlight real world, high impact mobile research that is relevant to the key discipline of Mobile HCI. Thus, the tutorial will be application rather than academically focused. The tutorial will highlight the wide range of mHealth applications available that go far beyond trackers and behavior change tools and encourage researchers to look beyond consumer applications in their research. Four key areas of mHealth applications will be covered including Apps for the HealthyWell, mHealth in Hospitals, Practice and Clinical Apps and Patient Apps and will cover applications for health assessment, treatment and triage, behavior change, chronic illness, mental health, adolescent health, rehabilitation and age care with a focus on the need for rigorous evaluation and efficacy analysis.
Mobile technology can help bridge health systems gaps and improve reproductive, maternal, newborn and child health outcomes. It has the potential to give every family access to information and services, support health workers, and create a more accountable health system. There are now over 137 mHealth projects at Johns Hopkins using mobile tools in various ways, such as providing education and referrals to communities, decision support and monitoring for health workers, and improving data collection and reporting across the health system. Rigorous evaluation is still needed to demonstrate the impact of mHealth on health outcomes and health systems strengthening.
Remote Patient Monitoring System at Mayo ClinicPeachy Essay
The Remote Patient Monitoring (RPM) system at Mayo Clinic allows doctors to monitor patients' health from a distance. It involves collecting biometric data from patients through mobile devices and transmitting it to medical practitioners. Mayo Clinic developed its RPM system to address issues like rising patient admissions, high emergency room visits, and the need to improve access to specialty care. The system is managed by the Center for Connected Care and involves training for medical staff. Strict security and privacy measures protect patient data collected by the RPM system.
In real sense Smartphone is a mobile phone with advanced features and functionality beyond traditional functionalities like making phone calls and sending text messages. The Smartphone are equipped with the capabilities to display photos, play games, play videos, navigation, built-in camera, audio/video playback and recording, send/receive e-mail, built in apps for social web sites and surf the Web, wireless Internet and much more.The penetration of Mobiles is more than 100% in the developed markets and is rapidly gaining acceptance in the developing regions such as Asia-Pacific, Latin America and Africa. The rising exposure to smartphones with technologies such as 4G and 5G networks will further promote the adoption of mobile devices in most sectors,over half of mobile phone users globally will have smartphones in 2018
Mobile devices are enforcing its use in all aspects of life, health care is one major area where mobile device could enhance operations, or improve quality and efficincy. Here is a presentation I gave at HIMSS which may be useful to you if you are considering using mobile device in your health care discpline.
This document provides an overview of drugs, medical devices, clinical trials, healthcare IT, and regulations. It discusses the types and administration of drugs. It describes medical devices and their types. It explains the objectives, design, and types of clinical trials. It discusses the role of IT in clinical trials and healthcare, including clinical trial management systems and electronic health records. It provides information on the healthcare and clinical trial management systems market. Finally, it lists some key regulating bodies and regulations.
mHealth Israel_Digital Health Regulation and the FDALevi Shapiro
Presentation by Bethany Hills, Partner, Mintz Levin: Digital Health Regulation and the FDA. Includes overview of the 21st Century Cures Act, Definition of a medical device, device approval basics, software as a Medical Device (SaMD), FDA Digital Health Activities, mobile medical applications, regulated mobile medical applications, Enforcement discretions of MMA, Clinical Decision Support, 3060 Clarifying Health Software Regulation, Classification Process,
pharmacogenomics, current regulatory efforts to ensure and promote innovationscomplianceonline123
It covers the new and expected regulations and their effects on use of pharmacogenomics in industry. PharmacoGenomics Data, genetic tests and Biomarkers, FDA guidances and federal initiatives, EMEA, Clinical Genomics data standards will explore medicine landscape.
Telemedicine provides healthcare at a distance using telecommunications technology. It has grown from focusing on increasing access to now emphasizing convenience and cost reduction. Store-and-forward and home-based telemedicine have evidence for treating chronic diseases, while office/hospital telemedicine is effective for verbal interactions in specialties like neurology and psychiatry. Current trends include expanding telemedicine to more chronic conditions and migrating services from clinical settings to homes and mobile devices. However, reimbursement remains limited and fragmented while quality of remote care compared to in-person visits requires more evidence. Proper guidelines, standards, training and balancing innovation with risk-based regulation can maximize telemedicine's benefits while minimizing harms.
Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.
This document discusses challenges and opportunities in managing data for personalized medicine. It begins with an overview of personalized medicine and the role of information and biomarkers. There is currently a deluge of diverse data from sources like omics, IoT, social media and mHealth. Biomarkers and computational techniques help reduce complexity and support integrative models. However, effective data capture, integration and interpretation require addressing issues like interoperability, security and privacy compliance. Personalized medicine is transforming healthcare to be more data-driven and patient-centric.
1. The healthcare informatics industry utilizes information technologies and management strategies to improve processes and efficiency in healthcare. McKesson Technology Solutions is a major player providing clinical software, pharmacy automation, and other IT services to hospitals.
2. McKesson's revenues have increased each year from $108 billion in 2008 to $112 billion in 2009. They are ranked 14th on the Fortune 500 list. McKesson provides solutions for electronic health records, computerized physician order entry, and decision support systems.
3. Trends in the industry include a focus on digitizing paper records, developing automated decision support systems using electronic data, and automating patients' medical histories. Regulatory acts are also driving increased IT adoption,
HealthTech is a prominent economic sector focused on innovations in treatment, diagnosis, and data protection using technologies like AI and blockchain. Global HealthTech spending was $9.5 trillion in 2018 and is projected to reach $10.059 trillion annually by 2022. ZYMR provides various HealthTech solutions including patient and clinical apps, EHR integration, health analytics, IoT, and service orchestration. Case studies highlight a health robotic device managing medication and activities, and a solution integrating behavioral health apps with EHR systems.
mHealth Israel_Ellen Janos_Healthcare Partner_Mintz Levin_ US Regulatory Envi...Levi Shapiro
This document summarizes US regulatory trends for mHealth opportunities from 2015 and beyond. Key points include:
1) The Affordable Care Act promotes new patient care models using mHealth technologies like remote patient monitoring and digital tools to engage patients, and has appropriated $10 billion for innovative payment models.
2) Both private markets and government agencies like CMS provide funding and collaboration opportunities for mHealth. Medicare is also reimbursing for some telemedicine services.
3) Regulators like HHS, FDA, FCC, and FTC provide guidance on issues like data privacy, security and regulation of medical devices and apps, but debate continues on reducing burdens to promote innovation while ensuring patient safety.
4
Artificial Intelligence and Machine Learning in HealthcareChristine Shepherd
Artificial Intelligence (AI) and Machine Learning (ML) have emerged as transformative technologies within the healthcare sector. These advanced computational tools offer the potential to revolutionize medical diagnosis, treatment, and patient care. Through the analysis of vast datasets, AI and ML can identify patterns, make predictions, and assist healthcare professionals in making more informed decisions. Applications range from image recognition in radiology to drug discovery, personalized treatment recommendations, and the enhancement of administrative processes. As these technologies continue to advance, they hold great promise for improving healthcare outcomes and efficiency. However, their implementation also raises ethical, regulatory, and security considerations that must be carefully addressed to ensure their responsible use in healthcare settings.
Regulatory Considerations in Mobile ProgramsDale Cooke
This presentation looks at some of the unique considerations in developing mobile programs, especially mobile apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps. Topics covered include:
* FDA’s finalized Mobile Medical Applications—Guidance for Industry and Food and Drug Administration Staff
* Determination of whether a mobile app is a medical device subject to FDA enforcement action
* Scope of FDA’s regulatory discretion regarding mobile apps
* FDA’s conflicting guidance on dosage apps
* How to meet key requirements of promotional labeling in mobile programs
* The growing area of mobile apps as promotional messaging platforms
This presentation has appeal for anyone interested in adopting mobile tactics, whether that interest is in developing medical devices or making use of mobile tactics to promote pharmaceuticals or biologics.
The framework flow chart shown in this presentation is available here: http://ow.ly/qMxse
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
http://www.alfonsogadea.es/apps-salud-poniendo-orden/
The pharmaceutical industry is facing many challenges today including declining drug approvals, rising generics competition, increased regulatory scrutiny, and a broken R&D process. Proposed changes like high-throughput screening and biomarkers have failed to significantly improve R&D productivity. Outsourcing drug development and focusing on commercialization may be a solution. Healthcare is also transitioning to personalized and preventative care focused on diagnosis over acute treatment, making patients more proactive consumers. Pharmaceutical companies will need new business models that integrate with changing healthcare systems.
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
This document provides guidance for industry and FDA staff on mobile medical applications (mobile medical apps). It defines key terms related to mobile platforms, mobile apps, and mobile medical apps. Mobile medical apps are a subset of mobile apps that meet the definition of a medical device and are subject to FDA regulatory oversight if they could pose risks to patient safety if not functioning properly. The guidance outlines the FDA's approach to regulating mobile medical apps based on their intended use and functionality rather than the platform. It also provides examples of mobile apps that would and would not be regulated as medical devices.
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...CRF Health
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and
potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential
benefits and risks to public health represented by these apps. The FDA is issuing this guidance
document to inform manufacturers, distributors, and other entities about how the FDA intends to
apply its regulatory authorities to select software applications intended for use on mobile
platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad
applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
Big Data, Health Outcomes & Marketing by Ben Wolin Everyday Health
This document discusses how big data from health interactions, medical claims, prescriptions, and mobile devices can be used to improve health outcomes and marketing. It provides examples of companies using data to better manage diseases like diabetes and asthma, improve medication adherence, and personalize health engagement and messaging. While data offers opportunities, the document stresses the importance of responsible use and protecting user privacy.
The document discusses trends impacting the healthcare industry and their implications for healthcare marketers. It summarizes that the industry is undergoing unprecedented changes driven by structural challenges, the Affordable Care Act, personalized medicine, and advances in health IT, digital, social and mobile technologies. These changes are impacting drug development, healthcare delivery, and pricing and payment models. The document also discusses trends specifically in pharmaceuticals/biotechnology, diagnostics/personalized medicine, and healthcare IT/analytics and the challenges they pose for healthcare marketers.
Startup weekend presentation. The team won "best use of government data" for creating a business called "Pineapple Food." This is the presentation from the July 10, 2012 presentation to the Worldbank on the topic (given by Marvin Ammori).
This document summarizes electronic health record (EHR) adoption trends among ambulatory care physicians from 2005 to 2010. It defines ambulatory care, EHRs, and levels of EHR adoption. Charts show EHR adoption rates increasing over time but meaningful use adoption rates remaining low at 6%. The document concludes that new financial incentives and regulations under HITECH are aimed at increasing meaningful EHR adoption rates.
Overview of Meaningful Use, Stage One. Presented to Georgetown's Health Information System's class on 4/14//11. Only difference from previous lectures is the addition of slides on adoption sentiment.
Meaningful Use Stage One, with CertificationJess Jacobs
The document discusses the requirements for achieving meaningful use of electronic health records under the Medicare and Medicaid EHR incentive programs. To qualify for incentive payments, eligible professionals and hospitals must meet core objectives such as maintaining active medication lists, recording smoking status, and reporting clinical quality measures electronically. They must also meet menu objectives such as incorporating lab results, generating patient lists, and providing patient-specific education. The incentives provide payments from 2011-2021 to professionals who demonstrate meaningful use each year, with penalties beginning in 2015 if usage requirements are not met.
In Spring of 2010 I was on a Georgetown student consulting team that worked on figuring out if it was possible to detect Medicaid fraud from #opendata in small, medium, and large states. This is the database work behind that project.
In Spring of 2010 I was on a Georgetown student consulting team that worked on figuring out if it was possible to detect Medicaid fraud from #opendata in small, medium, and large states.
The Health Systems Administration program at Georgetown has its students complete case projects for a fictional community, Middleboro. Throughout the program we created several deliverables: Community Profile, Community Health Assessment, Strategic Plan, Marketing Plan, and Business Plan.
The Health Systems Administration program at Georgetown has its students complete case projects for a fictional community, Middleboro. Throughout the program we created several deliverables: Community Profile, Community Health Assessment, Strategic Plan, Marketing Plan, and Business Plan.
The Health Systems Administration program at Georgetown has its students complete case projects for a fictional community, Middleboro. Throughout the program we created several deliverables: Community Profile, Community Health Assessment, Strategic Plan, Marketing Plan, and Business Plan.
The Health Systems Administration program at Georgetown has its students complete case projects for a fictional community, Middleboro. Throughout the program we created several deliverables: Community Profile, Community Health Assessment, Strategic Plan, Marketing Plan, and Business Plan.
The Health Systems Administration program at Georgetown has its students complete case projects for a fictional community, Middleboro. Throughout the program we created several deliverables: Community Profile, Community Health Assessment, Strategic Plan, Marketing Plan, and Business Plan.
My very first PowerPoint presentation. Ever. This reported on The school didn't do PPT so my dad borrowed a projector from his office. Then I was told I relied on the ppt too much. Whoops!
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Light House Retreats: Plant Medicine Retreat Europe
Federal mHealth Policy 101
1. @jess_jacobs @FHCInnovation
#HIMSS13 #mHIMSS #Policy
Federal mHealth Policy 101
Jess Jacobs, MHSA, CPHIMS
DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily represent official policy or position of HIMSS.
2. @jess_jacobs @FHCInnovation
#HIMSS13 #mHIMSS #Policy
Conflict of Interest Disclosure
Jessica Jacobs, MHSA, CPHIMS
Has no real or apparent
conflicts of interest to report.
3. @jess_jacobs @FHCInnovation
#HIMSS13 #mHIMSS #Policy
Learning Objectives
• Recognize the oversight of seven federal
agencies/opdivs on mHealth related technologies
• Distinguish between federal policies that apply to
mHealth product development verses mHealth
adoption
• Identify federal policies relevant to their
organization's application of mHealth
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mHealth is the use of mobile and
wireless devices to improve health outcomes,
healthcare services, and health research.
- 2011 NIH Consensus Group
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That seems general…
Who • Patient? Provider?
• Data collected? Data
What disseminated? Analysis?
Recommendations?
When • Home? Hospital? Car?
Where • Broadband? Wifi? Wired?
• Treat a disease? General
Why
wellness?
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Policy 101: Policy Process
Hears a Passes a Signs into Translates Complies
need Bill Law into Policy
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Policy 101: The Cabinet
National Institute of
Department of Commerce
United States Executive Branch
Standards and Technology
(DOC)
(NIST)
Food and Drug
Administration (FDA)
Office of the National
Coordinator for Health IT
(ONC)
Department of Health and
Office of the Secretary (OS)
Human Services (HHS)
Office for Civil Rights (OCR)
Centers for Medicare and
Medicaid Services (CMS)
Federal Communications
Commission (FCC)
Independent Offices
Federal Trade Commission
(FTC)
15. @jess_jacobs @FHCInnovation
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Safety and Efficacy: FDA
• Food and Drug Administration is responsible for vetting the safety
and efficacy of medical devices.
• Authority:
– Food, Drug, and Cosmetic Act 1938
• FDA is responsible for regulating medical devices
– FDA Safety and Innovation Act 2012, Section 618
• FDA, FCC, ONC will coordinate on regulatory framework.
• Recent Guidance: Mobile Medical Apps Guidance (MMA)
• If the mobile medical app falls within a specific medical device classification or
augments functionality to a specific medical device classification, manufacturers are
immediately subject to meet the requirements of that classification (either I, II, or III).
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Safety and Efficacy: FDA Devices
• Medical Devices are classified Class I, II, and III.
• Based on Intended Use and Indications for Use
Class 1: Not substantially important to health
Class 2: Perform as indicated
General Controls
Class 3: Sustain Life
• Listing Special Controls
• Premarket Notification • Labeling
• Recall Processes
Premarket Approval
• Post Market
• Good Manufacturing Surveillance
Processes • Performance Standards
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Safety and Efficacy: FDA Device
Anything that isn’t a drug and is used to:
Diagnose
Cure
Mitigate
Treat
Prevent
a disease or condition.
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Safety and Efficacy: FDA MMA
Displaying, Storing, or Transmitting
• If a mobile medical app allows for the display/storage/or
transmission of patient-specific information (PHI) in its
original format, it is a medical device. This category of
mobile medical apps are primarily used as secondary
displays (and not for primary diagnosis/treatment
decisions) and will only require Class I requirements.
Controlling connected medical devices
• If a mobile medical app allows for the control of another
medical device, it must adhere to the regulations
applicable to the connected device. These mobile
medical apps can control the use, function, modes, or
energy source of a regulated medical device.
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Safety and Efficacy: FDA MMA
Mobile platform transformation
• If a mobile medical app transforms a mobile
platform into a regulated medical device, it is
regulated under the class applicable to its intended
use.
Interpretation of Medical Device Data
• If a mobile medical app is intended to analyze or
interpret data from a medical device for the
purposes of creating alarms, recommendations, or
information, is considered an accessory to the first
medical device and regulated under the first medical
device’s class.
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Safety and Efficacy: FDA MMA
• Possibly Regulated: “Regulatory discretion will be used regarding mobile apps which meet
the FD&C’s device definition but are not an accessory to a regulated device or intended to
transform a mobile platform into a regulated device. “
Applications which remind people to manually input information
for logging/tracking/graphing.
Patient education data viewers.
Organization of personal health information - such as dosages,
calories, doctor appointments, lab results, and symptoms.
Over the counter medication lookup applications which provide
the information available on drug labels.
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Safety and Efficacy: FDA MMA
Not regulated:
– Electronic versions of reference
materials that do not contain patient-
specific information
– Health/wellness applications that do
not intend to cure, treat, or diagnose
– Automated billing, inventory,
appointment, or insurance
transactions
– Generic aids (audio recording, note
taking, etc)
– mobile EHRs or PHRs
22. @jess_jacobs @FHCInnovation
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Safety and Efficacy: FCC
• The FCC sets Specific Absorption Rate (SAR) limits to
protecting human health from negative RF (Radio
Frequency) exposure under Part 95.
• Some examples of devices which might fall under FCC
oversight include insulin/glucose monitors, wireless heart
monitors, medical radios, and/or cell phones.
• Authority:
– Communications Act 1934
– Telecommunications Act 1996
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Safety and Efficacy: FTC
• The FTC sanctions individuals
who advertise products
inappropriately.
– False or misleading
– Omits material facts
– Act or practice that is unfair
– Cause substantial harm to
consumers (CBA)
• Authority:
– Federal Trade Commission Act 1914
(Section 5)
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Communication
• FCC is responsible for making sure devices are able to
communicate without interference.
• FCC technical requirements apply to devices that posses the
potential to cause radio frequency
– may include the granting of an FCC ID number.
• Authority:
– Communications Act 1934
– Telecommunications Act 1996
– Food and Drug Administration
Safety and Innovation Act 2012
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Communication: FCC Spectrum Allocation
• Medical Radio Communications Service (MedRadio): medical
devices for transmitting data containing operational, diagnostic
and therapeutic information associated with a medical implant
device or medical body worn devices
• Medical Micropower Networks (MMNs): wireless medical devices
that can be used to restore functions to paralyzed limbs
• Medical Body Area Networks (MBANs): networks of body-worn
wireless sensors that transmit patient data to a health care
provider
• Wireless Medical Telemetry Service (WMTS): a short distance
data communication service for transmitting patient medical
information to a central monitoring location in a medical facility
• Medical devices may also operate under the rules for unlicensed
devices under Part 15 in any frequency band available under that
Part.
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Communication: Standards
• While not mandated, many standards
organizations work in collaboration with federal
partners.
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Adoption
Running the Show
Running the Show Backup Singers
Backup Singers
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Adoption: CMS
• Centers for Medicare and Medicaid Adoption (CMS) sets
reimbursement guidelines and runs incentive programs
for hospitals and providers.
• Authority:
– Social Security Act 1965
– American Recovery and Reinvestment Act 2010
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Adoption: CMS, ONC, and NIST
• Meaningful Use promotes the adoption of EHRs.
• Operational Rule:
• HHS Center for Medicare and Medicaid Services (CMS)
writes the rule and administers the provider incentive/penalty
program.
• Technical Rules:
• HHS Office of the National Coordinator for Health IT (ONC) is
responsible for the Standards and Certification Rule.
• NIST provides test criteria for EHRs to become certified.
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Adoption
Stages One and Two Stage Three and Beyond
• Create the capacity for
electronic episodes of care
• How to incorporate patient
generated data
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Privacy and Security: OCR and HIPAA
• HHS Office for Civil Rights promulgates rules to
protect consumer health information.
• Authority:
– Health Insurance Portability
and Accountability Act 1996
– American Recovery and
Reinvestment Act 2010
35. @jess_jacobs @FHCInnovation
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Privacy and Security: OCR and HIPAA
• HIPAA applies to Protected Health Information
(PHI):
– all "individually identifiable health information"
– any form or media: electronic (ePHI), paper, or oral.
– held or transmitted by a covered entity or its business
associates. health care providers, health plans, health
care clearinghouses, vendors
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Privacy and Security: HIPAA
• Rules:
– OCR Privacy Rule:
• Gives the consumer rights over
his/her PHI
• Sets rules and limits on who can
view or receive PHI
– OCR: Security Rule:
• administrative, physical, and
technical safeguards for PHI
• Requires a risk assessment
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Privacy and Security: FTC
• The FTC protects consumer data
privacy
– Special rules for minors
• FTC Health Breach Notification Rule:
– Primarily applies to Personal Health
Records
• Authority:
• Federal Trade Commission Act 1914
• Children’s Online Privacy Protection Act
1998
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What’s this mean? Question of Who.
Manufacturer Healthcare Provider
• Initiates Specifications • Hospital
• Designs • Physicians
• Labels
• Creates a software
system or application in
whole or from multiple
software components
41. @jess_jacobs @FHCInnovation
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Manufacturer
Adoption Safety/Efficacy Communication Privacy/Security
Make sure device If device, undergo Meet
interoperability is FDA review and appropriate FCC
compatible with oversight. technical
Development
ONC/NIST specifications
specifications. Meet FCC and registration
requirements for requirements.
Make sure not RF.
infringing on
patents
If device, If collecting PHI, fulfill
Deployment
postmarket HIPAA requirements
surveillance. Have appropriate
disclaimers and
Don’t oversell to safeguards.
avoid FTC oversight.
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Healthcare Providers and Facilities
Adoption Communication Privacy/Security
• Utilize • Use • fulfill all HIPPA
certified EHRs appropriate requirements
spectrum (Security
specifications Assessment)
45. @jess_jacobs @FHCInnovation
#HIMSS13 #mHIMSS #Policy
Thank You! Questions?
Jess Jacobs
jjacobs@healthcareinnovation.us
Special thanks to the
2011-12 mHIMSS Policy Workgroup
W. Bradley, N. Falcone, R. Kennis, L. Kim, M. Kuriland, & D. Wong
for researching the whitepaper this presentation is based on.
Editor's Notes
This presentation, for providers and developers alike, will serve as an introduction to Federal mHealth policies from the following agencies: HHS (CMS, FDA, OCR, ONC), NIST, FTC, FCC.
Definition
Who: Who is the product intended to be used by?What: How does the product record and analyze the information? When: What settings can the product be used in – different requirements for clinical vs home useWhere: What connectivity is required for successful utilization of the product? Why: Why is the product used?