EU General Data Protection Regulation top 8 operational impacts in personal c...Erik Vollebregt
Presentation to the Personal Connected Health Alliance about the top 8 operational impacts of the EU General Data Protection Regulation on companies in the personal connected health field.
EU Medical Device Clinical Research under the General Data Protection RegulationErik Vollebregt
Presentation about medical devices patient data management under the EU General Data Protection Regulation at the Medical Device Clinical Research Conference in November 2015
Presentation of Vishal Gulati (Draper Esprit, Venture Partner; Horizon Discovery Group PLC, Board Director) at the Forum of the BioRegion of Catalonia, organized by Biocat.
EU General Data Protection Regulation top 8 operational impacts in personal c...Erik Vollebregt
Presentation to the Personal Connected Health Alliance about the top 8 operational impacts of the EU General Data Protection Regulation on companies in the personal connected health field.
EU Medical Device Clinical Research under the General Data Protection RegulationErik Vollebregt
Presentation about medical devices patient data management under the EU General Data Protection Regulation at the Medical Device Clinical Research Conference in November 2015
Presentation of Vishal Gulati (Draper Esprit, Venture Partner; Horizon Discovery Group PLC, Board Director) at the Forum of the BioRegion of Catalonia, organized by Biocat.
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,
The regulation of software: Medicines, biologicals, blood, tissues and devicesTGA Australia
This presentation is an overview of the software regulated by the TGA, a brief introduction to the International Medical Device Regulators' Forum's Software as a Medical Device project and details of how the TGA takes a systems approach to the regulation of software.
Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their...Greenlight Guru
This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each.
The FDA Guidance Documents to be discussed:
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
The post-COVID Value Shift & How MedTech Companies can CapitalizeGreenlight Guru
The ongoing COVID-19 pandemic has fundamentally shifted the perception of value globally. The healthcare industry, and MedTech (Devices, Diagnostics and Digital Health) stand to benefit enormously. While the world waits for a vaccine, it has been MedTech companies and their solutions that have protected healthcare workers, kept patients alive, and been the focus of government policy and investment. The policy and funding shifts have been aligned to value-based healthcare principals, of which MedTech was already a leader. Discover how you can align your organization, and engage with key stakeholders to capitalize on this massive shift in value perception.
Takeaways:
- How the fundamental structure of healthcare is set to change
-How this fundamental change will benefit MedTech companies
-What you need to do in order to make this change sustainable within your organization
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Post Market Surveillance: If a Device is FDA Cleared or Approved, or EU CE Ma...Greenlight Guru
When a medical device is FDA Cleared/Approved or EU CE Marked, can we assume it’s safe and effective? In a word... NO! Post-market surveillance (PMS) is the process of watching devices perform while on the market. PMS is a vital component of the medical device lifecycle. Yet the med-tech industry has had a poor record when it comes to PMS. As a result, PMS requirements have been increasing in the US, the EU and around the globe.
Having an effective PMS system is important from both a regulatory and quality perspective. But can we assume if our PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not! This presentation will use the case study approach to take a broad look at medical device post-market surveillance including:
• What are the key elements of an effective PMS system?
• With increasing pre-market regulatory requirements, why do we still need PMS?
• Is passive PMS enough? What about active PMS?
• How can PMS be used for label expansions? Either via RCT and/or real-world evidence?
• What are the PMS challenges for the future? In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage!
The most fundamental expectation from the healthcare sector is that it provides a safe and reliable environment to serve patients. Medical supplies and equipment have also improved with technological advancements, making them easier to use, providing a better experience, and increasing their longevity. With advancement in technology, medical services can also be tracked for efficiency.
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,
The regulation of software: Medicines, biologicals, blood, tissues and devicesTGA Australia
This presentation is an overview of the software regulated by the TGA, a brief introduction to the International Medical Device Regulators' Forum's Software as a Medical Device project and details of how the TGA takes a systems approach to the regulation of software.
Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their...Greenlight Guru
This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each.
The FDA Guidance Documents to be discussed:
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Medical technologies and data protection issues - food for thoughtRenato Monteiro
Document prepared towards the modernization procedure of Council of Europe´s Convention 108 on the Protection of Personal Data. Available at: http://www.coe.int/t/dghl/standardsetting/dataprotection/TPD_documents/T-PD-BUR%282014%2904Rev%20-%20Medical%20Data%20%28By%20Renato%20Leite%29.pdf
The post-COVID Value Shift & How MedTech Companies can CapitalizeGreenlight Guru
The ongoing COVID-19 pandemic has fundamentally shifted the perception of value globally. The healthcare industry, and MedTech (Devices, Diagnostics and Digital Health) stand to benefit enormously. While the world waits for a vaccine, it has been MedTech companies and their solutions that have protected healthcare workers, kept patients alive, and been the focus of government policy and investment. The policy and funding shifts have been aligned to value-based healthcare principals, of which MedTech was already a leader. Discover how you can align your organization, and engage with key stakeholders to capitalize on this massive shift in value perception.
Takeaways:
- How the fundamental structure of healthcare is set to change
-How this fundamental change will benefit MedTech companies
-What you need to do in order to make this change sustainable within your organization
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Post Market Surveillance: If a Device is FDA Cleared or Approved, or EU CE Ma...Greenlight Guru
When a medical device is FDA Cleared/Approved or EU CE Marked, can we assume it’s safe and effective? In a word... NO! Post-market surveillance (PMS) is the process of watching devices perform while on the market. PMS is a vital component of the medical device lifecycle. Yet the med-tech industry has had a poor record when it comes to PMS. As a result, PMS requirements have been increasing in the US, the EU and around the globe.
Having an effective PMS system is important from both a regulatory and quality perspective. But can we assume if our PMS system meets the regulatory and quality requirements, that its effective? that its working? Absolutely not! This presentation will use the case study approach to take a broad look at medical device post-market surveillance including:
• What are the key elements of an effective PMS system?
• With increasing pre-market regulatory requirements, why do we still need PMS?
• Is passive PMS enough? What about active PMS?
• How can PMS be used for label expansions? Either via RCT and/or real-world evidence?
• What are the PMS challenges for the future? In this presentation, participants will learn best practices to avoid timely and costly mistakes as well as creative ways to use post-market surveillance to their advantage!
The most fundamental expectation from the healthcare sector is that it provides a safe and reliable environment to serve patients. Medical supplies and equipment have also improved with technological advancements, making them easier to use, providing a better experience, and increasing their longevity. With advancement in technology, medical services can also be tracked for efficiency.
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
EU regulatory frameworks - Legal challenges and opportunities for digital hea...DayOne
Presentation by Karin Schulze, Head of Medical Devices at SFL at the DayOne Expert Event Legal challenges and opportunities for digital health innovation
Regulation
Regarding the new MDR, the big question that arises is not only whether a piece of software falls under the definition of a medical device, but also who decides whether it does. At least in this regard the new regulation is clear: it is the regulator. Which means, according to Karin Shulze from SFL, that If a company offers an app which they do not consider a medical device themselves, but the regulator does, the distribution of this app will be stopped.
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Cloud Platform for Remote Patient Monitoring. Case: Stroke Remote Care.pselonen
Presentation at AI morning in April 13th at Tampere University of Technology Kampusklubi.
"AI Morning in April 13th experiments with a new distinctive concept and remixes together machine learning and analytics in the two verticals of healthcare and industry! There is a huge common ground in diagnostics of people and machines, and the same algorithms can be used in both. The presenters from healthcare and industry keynote a conversational networking forum in theme: 'Health: analytics'."
See http://www.aiaamu.fi/
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
Multidisciplinary care: a perspective from diagnosis and treatment of rare cancers. Casali P. Technical Conference: Multidisciplinary Care in Cancer as a model of health care quality (Madrid: Ministry of Health and Social Policy, 2010)
La mejor evidencia junto a la mejor organización: el reto de la coordinación profesional en atención oncológica. Sánchez de Toledo J. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
La mejor evidencia junto a la mejor organización: el reto de la coordinación profesional en atención oncológica. Ortiz H. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
La mejor evidencia junto a la mejor organización: el reto de la coordinación profesional en atención oncológica. Barnadas A. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
Experiencias y percepción de la atención integral de los pacientes con cáncer. Oriol Díaz de Bustamante I. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
Experiencias y percepción de la atención integral de los pacientes con cáncer. Moreno Marín P. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
La mejor evidencia junto a la mejor organización: el reto de la coordinación profesional en atención oncológica. Medina JA. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
Experiencias y percepción de la atención integral de los pacientes con cáncer. Fisas Armengol A. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
La mejor evidencia junto a la mejor organización: el reto de la coordinación profesional en atención oncológica. Ferro T. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
La mejor evidencia junto a la mejor organización: el reto de la coordinación profesional en atención oncológica. Díaz Mediavilla J. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
La mejor evidencia junto a la mejor organización: el reto de la coordinación profesional en atención oncológica. Ignacio A. Jornada Técnica: Atención Multidisciplinar en Cáncer como modelo de calidad asistencial (Madrid: Ministerio de Sanidad y Política Social, 2010)
The power of lifestyle interventions to prevent cardiovascular diseases. Tuomilehto J. Conference on Cardiovascular Diseases (Madrid: Ministry of Health and Social Policy; 2010).
Alcohol and chronic diseases: complex relations. Guillemont J. Conference on Cardiovascular Diseases (Madrid: Ministry of Health and Social Policy; 2010).
Risk Assessment and Management of Cardiovascular Diseases - an English Approach. Lynam E. Conference on Cardiovascular Diseases (Madrid: Ministry of Health and Social Policy; 2010).
Cardiovascular disease inequalities: causes and consequences. Capewell S. Conference on Cardiovascular Diseases (Madrid: Ministry of Health and Social Policy; 2010).
Addressing cardiovascular disease at EU level: tangible plans for the future. Hübel M. Conference on Cardiovascular Diseases (Madrid: Ministry of Health and Social Policy; 2010).
The impact of eHealth on Healthcare Professionals and Organisations: The Impact of ICT at Kaiser Permanente. Wiesenthal A. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)
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.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Surat @ℂall @Girls ꧁❤8527049040❤꧂@ℂall @Girls Service Vip Top Model Safe
From Servers to Medical Devices
1. From Servers to Medical Devices
Elisabethann Wright
Hogan & Hartson LLP, Belgium
Prof.Dr.med. Björn Berg
Director of Information Technology & Medical Engineering
University Hospital Heidelberg, Germany
Anne-Sophie Bricca
Director EMEA Legal Affairs, CaridianBCT, Belgium
Petra Wilson
Director, Internet Business Solutions Group
Cisco Systems
2. The legal landscape of medical
devices – the needs
Point-of-care diagnostic device for:
• Seamless integration of data at ward level
• Data integration to national summary EHR
• Anonymous data aggregated locally for
research purposes
• Routine automated device testing
Home monitoring device for:
• Patient clinical data collection
• Routine remote follow-up of patients
• Automated alert of the treating
physician
3. The legal landscape of medical
devices – legal issues
Medical Device Certification for physical medical
devices
Medical Device Certification for software which
supports devices
Local modifications of the devices - hardware and
software
Data processing of data from devices
Liability for use of on-site and off-site devices
4. What is a Medical Device?
The current Medical Device Directive defines a medical
device as:
• “any instrument, apparatus, appliance, software, material or other
article, whether used alone or in combination, including the
software intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for its
proper application, intended by the manufacturer to be used for
human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap;
• investigation, replacement or modification of the anatomy or of a
physiological process;
• control of conception;
• and which does not achieve its principal intended action in or on
the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means”.
5. What is an accessory?
An accessory is defined in the Directive as:
• “an article which whilst not being a device is intended specifically by its
manufacturer to be used together with a device to enable it to be used
in accordance with the use of the device intended by the manufacturer
of the device”.
• The European Commission Guideline (MEDDEV 2.1/1 April 1994),
provides:
• “the definition of "accessory" requires that the accessory is specifically
intended by the manufacturer of the accessory to be used together
with a device. The intended use of the accessory must be such as to
enable a device to be used in accordance with its intended use.
Therefore a product can only become an accessory to a medical
device if the manufacturer of such a product establishes an intended
use in conjunction with one or several medical devices.”
• The Directive provides that “accessories shall be treated as
medical devices in their own right”.
6. Software as a Medical Device
• No specific definition of “software” in either regulation or
guidance at present. However the Medical Devices
Directive provides some direction:
• “For devices which incorporate software or which are medical
software in themselves, the software must be validated
according to the state of the art taking into account the
principles of development lifecycle, risk management, validation
and verification” (Annex 1 Essential Requirements, point 12.1a)
• “Stand alone software is considered to be an active medical
device” (Annex IX Classification criteria, point 1.4)
• “Software, which drives a device or influences the use of a
device, falls automatically in the same class” (Annex IX
Classification criteria, point 2.3)
• Harmonised international standards provide guidance:
• EN 62304:2006 Medical device software - Software life-cycle
processes (IEC 62304:2006).
7. Data Flows
Pers. Data Tech. Data
academic
nephrologists
Scientific Data
Tech. Data
home Point of care
monitoring Diagnostic
devices US Vendor
Device
Technical
Pers. Data support
Patient
Care
Pers. Data Providers
8. Directive 95/46/EC
Scope: protection of individuals with regards to the processing of
personal data and on the free movement of such data.
Appllicability: to data processed by automated means and data
contained in or intended to be part of non automated filing systems.
Content: strict limits on the collection and use of personal data and
demands that each Member State set up an independent national
body responsible for the protection of these data.
9. Personal Data
Definition:
Chapter I – Article 2 (a)
“Any information relating to an identifiable
natural person (“data subject”); an identifiable
person is one who can be identified, directly or
indirectly, in particular by reference to an
identification number or to one or more factors
specific to his physical, physiological, mental,
economic, cultural or social identity”.
10. Derogation
Article 8.3: “processing of data concerning
health is (authorized when) required for the
purposes of preventive medicine, medical
diagnosis, the provision of care or treatment or
the management of health-care services, and
where those data are processed by a health
professional subject under national law or rules
established by national competent bodies to the
obligation of professional secrecy or by another
person also subject to an equivalent obligation of
secrecy.”
11. Data Controller’s obligations
Controller’s obligations:
• Collection of the data subject's consent (Article 2(h))
• To give information to the data subject (Article 10) :
• the identity of the controller and of his representative, if any;
• the purposes of the processing
• the recipient(s)
• To provide a right of access to and a right to rectify
(Article 12)
• To ensure the confidentiality of processing (Article 16)
• To ensure the security of processing (Article 17)
• To notify the supervisory authority (Article 18)
• To act as a Data exporter in case of
transfer to a third country.
12. Liability Flows
Vendor
Hospital / care Health care
Patient institution professional
13. Questions of Liability:
Key actors
5 potentially groups of people have
liability issues:
• The device manufacturer(s)
• The Hospital
• The Healthcare Professionals
• The Internet Service Provider
• The patient
14. Questions of Liability
Relevant EU level Legislation
Liability for defective products
(Dir. 85/374/EC & Directive 1999/34/EC)
General product safety
(Dir. 2001/95/EC)
Sale of consumer goods
(Dir. 1999/44/EC)
Information society services and
eCommerce
(Dir. 2000/31/EC)
15. Questions of Liability
Key Concepts
• Professional liability for good healthcare services
• Institutional and Vicarious Liability of hospital
• No-fault Liability
• Special liability of Information Society Services
providers
• Contributory Liability of Patients