Telemedicine encompasses a variety of remote healthcare services delivered through technology. However, the legal landscape struggles to regulate telemedicine due to its complexity and interactions between healthcare, devices, data protection and other regulations. Telemedicine falls under provisions for cross-border healthcare services, but issues arise regarding professional qualifications and medical device regulations. Strict data protection laws also apply to health data processed and transmitted during telemedicine. As telemedicine continues advancing, companies must navigate these various legal requirements while regulatory frameworks work to better address this evolving area of healthcare.
Today's Healthcare Technology and the Regulatory StandpointAkshay Anand
Poster titled 'Today's Healthcare Technology and the Regulatory Standpoint' presented at 67th IPC (Indian Pharmaceutical Congress), held at Mysuru in December 2015.
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
The Health Insurance Portability and Accountability Act Kartheek Kein
HIPAA is the acronym of the Health Insurance Portability and Accountability Act of 1996. The main purpose of this federal statute was to help consumers maintain their insurance coverage, but it also includes a separate set of provisions called Administrative Simplification.
Today's Healthcare Technology and the Regulatory StandpointAkshay Anand
Poster titled 'Today's Healthcare Technology and the Regulatory Standpoint' presented at 67th IPC (Indian Pharmaceutical Congress), held at Mysuru in December 2015.
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
The Health Insurance Portability and Accountability Act Kartheek Kein
HIPAA is the acronym of the Health Insurance Portability and Accountability Act of 1996. The main purpose of this federal statute was to help consumers maintain their insurance coverage, but it also includes a separate set of provisions called Administrative Simplification.
Transparency and confidentiality of medical devices clinical information Erik Vollebregt
Presentation at the Zürich Medtech & Pharma Innovation at the Interface conference about transparency of medical devices clinical information under the medical devices and IVD regulation proposals
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
David Farber (http://bit.ly/2DFnvJ1), Head of the FDA and Reimbursement Practice at King & Spalding in Washington DC, leads a workshop for medtech and digital health companies seeking US reimbursement. He brings 30+ years of experience in US Healthcare reimbursement, lobbying and FDA regulatory issues. In addition to ongoing reimbursement challenges, 2020 will see a fundamental transformation in US medical reimbursement (http://bit.ly/2YWlYbt), particularly in digital health. That includes 394 Current Procedural Terminology (CPT) code changes, 248 new codes, 71 deletions and 75 revisions
The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.
Health and Fitness Tracking Devices - Trends 2014 | Top Players: Apple, Nike,...Rahul Dev
Health & Fitness Tracking Trends: 2014
Rahul Dev is a recognized industry expert in Intellectual Property, Patent Strategy & Technology Consulting. He assists clients in formulating profitable and sustainable Patent & IP Strategy for international business.
As a Patent Attorney & Business Lawyer, he is invited to speak at various International events, News Channels, National & International Conferences, Workshop for CEOs, Govt. Events.
He is an active blogger & his views have been published by International Publications, Economic Times, Law Journals, Tech Magazines, Digital News Networks.
International Law Firms, Executives from Technology Corporations, Investors, Entrepreneurs & Startups worldwide (US, EU & Asia Pacific) consult him on Patents, Trademarks, Intellectual Property Rights, Product Strategy, Technology Development, Corporate & Securities Law, Technology Ventures, Financing, Fundraising and International Business Advisory.
He works closely with patent attorneys worldwide for patent drafting, prior art searches & patent research (analytics), in field of Software Patents, Wireless Communications Patents, Mechanical Patents, Medical Devices, Healthcare, Life Sciences & Genetic Engineering Patents.
He serves as SME & Startup Mentor @SMBconnect.in & visiting faculty at Global Institute of Intellectual Property (GIIP).
His qualifications are BS, MS, MBA & LLB (JD).
He is member of Bar Council of India, Delhi Bar Council, Indian Patent & Trademark Office, Delhi High Court Bar Association.
In past, Rahul has worked with Amarchand Mangaldas, largest Indian Law Firm.
As a business savvy technology lawyer & strategic patent attorney, he serves as:
✈ Founder & Director, Tech Corp International Consultants (Singapore), APAC Technology, Business & Management Consulting Company
✈ Founder & Partner, Tech Corp Legal LLP, Indian law firm (BioCorpLegal & CyberCorpLegal Services)
✈ Closely associated with two international patent law firms (US, Asia)
Specialties: Litigation, Patent Litigation, Patent Infringement, Corporate & IP Strategy, Startups: Incorporation, Funding, Brand Management, Contracts & Agreements, Legal Research, SWOT, Corporate Governance, Due-diligence, Mergers & Acquisitions, Antitrust & Competition Laws, Regulatory Affairs, Freedom-to-Operate, Patent Drafting, Claim Drafting, Patent Searches, Office Actions Response, USPTO Patent appeal briefs, Patent Invalidation Analysis, Patent Opposition, Product-Claim Mapping, Patent Enforcement
With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations.
In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Explanation of how medical device information in the AccessGUDID web site will be used in Electronic Health Records NLM device manufacturers submit to the FDA is made available at the National from the National Library of Medicine.
Transparency and confidentiality of medical devices clinical information Erik Vollebregt
Presentation at the Zürich Medtech & Pharma Innovation at the Interface conference about transparency of medical devices clinical information under the medical devices and IVD regulation proposals
Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.
David Farber (http://bit.ly/2DFnvJ1), Head of the FDA and Reimbursement Practice at King & Spalding in Washington DC, leads a workshop for medtech and digital health companies seeking US reimbursement. He brings 30+ years of experience in US Healthcare reimbursement, lobbying and FDA regulatory issues. In addition to ongoing reimbursement challenges, 2020 will see a fundamental transformation in US medical reimbursement (http://bit.ly/2YWlYbt), particularly in digital health. That includes 394 Current Procedural Terminology (CPT) code changes, 248 new codes, 71 deletions and 75 revisions
The Medical Council of India regulates uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. Official registration of doctors with recognized medical qualifications is controlled by the council, and procedures have been laid out under the Indian Medical Council Act 1956 and Indian Medical Degree Act 1916. Although there are no legal constraints specifically dealing with methodology of executing or dispensing medical services in India, various laws including the Drugs and Cosmetics Act, 1940 define negligence; criminal intent; sale, manufacture and distribution of drugs etc., while judicial precedent and case laws determine medical negligence on a case by case basis. The healthcare service provider adopting telemedicine methods of medical practice must ensure that medical consultation, prescriptions, treatment and drugs are dispensed only in accordance with legal provisions and guidelines regulating the medical and healthcare sector in India.
Health and Fitness Tracking Devices - Trends 2014 | Top Players: Apple, Nike,...Rahul Dev
Health & Fitness Tracking Trends: 2014
Rahul Dev is a recognized industry expert in Intellectual Property, Patent Strategy & Technology Consulting. He assists clients in formulating profitable and sustainable Patent & IP Strategy for international business.
As a Patent Attorney & Business Lawyer, he is invited to speak at various International events, News Channels, National & International Conferences, Workshop for CEOs, Govt. Events.
He is an active blogger & his views have been published by International Publications, Economic Times, Law Journals, Tech Magazines, Digital News Networks.
International Law Firms, Executives from Technology Corporations, Investors, Entrepreneurs & Startups worldwide (US, EU & Asia Pacific) consult him on Patents, Trademarks, Intellectual Property Rights, Product Strategy, Technology Development, Corporate & Securities Law, Technology Ventures, Financing, Fundraising and International Business Advisory.
He works closely with patent attorneys worldwide for patent drafting, prior art searches & patent research (analytics), in field of Software Patents, Wireless Communications Patents, Mechanical Patents, Medical Devices, Healthcare, Life Sciences & Genetic Engineering Patents.
He serves as SME & Startup Mentor @SMBconnect.in & visiting faculty at Global Institute of Intellectual Property (GIIP).
His qualifications are BS, MS, MBA & LLB (JD).
He is member of Bar Council of India, Delhi Bar Council, Indian Patent & Trademark Office, Delhi High Court Bar Association.
In past, Rahul has worked with Amarchand Mangaldas, largest Indian Law Firm.
As a business savvy technology lawyer & strategic patent attorney, he serves as:
✈ Founder & Director, Tech Corp International Consultants (Singapore), APAC Technology, Business & Management Consulting Company
✈ Founder & Partner, Tech Corp Legal LLP, Indian law firm (BioCorpLegal & CyberCorpLegal Services)
✈ Closely associated with two international patent law firms (US, Asia)
Specialties: Litigation, Patent Litigation, Patent Infringement, Corporate & IP Strategy, Startups: Incorporation, Funding, Brand Management, Contracts & Agreements, Legal Research, SWOT, Corporate Governance, Due-diligence, Mergers & Acquisitions, Antitrust & Competition Laws, Regulatory Affairs, Freedom-to-Operate, Patent Drafting, Claim Drafting, Patent Searches, Office Actions Response, USPTO Patent appeal briefs, Patent Invalidation Analysis, Patent Opposition, Product-Claim Mapping, Patent Enforcement
With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations.
In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Explanation of how medical device information in the AccessGUDID web site will be used in Electronic Health Records NLM device manufacturers submit to the FDA is made available at the National from the National Library of Medicine.
Top 15 cele mai frumoase locuri de vizitat in Romania Mihai Cojocaru
Ne asumăm faptul că topul nostru nu are pretenția de se autointitula o selecție desăvârșită, exhaustivă, ci mai degrabă o înșiruire de alegeri subiective a cărei umilă ambiție a fost aceea de a nu lăsa nemulțumite prea multe dintre regiunile mioritice.
Citește mai mult pe
http://www.momondo.ro/inspiratie/locuri-de-vizitat-romania/#xMhtKlPd2oPvPofH.97
Audio credit:
On My Way Kevin MacLeod (incompetech.com)Licensed under Creative Commons: By Attribution 3.0 Licensehttp://creativecommons.org/licenses/by/3.0/
BOARD OF GOVERNORS In supersession of the Medical Council of India
Telemedicine Practice Guidelines Enabling Registered Medical Practitioners to Provide Healthcare Using Telemedicine
These Guidelines have been prepared in partnership with NITI Aayog
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
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
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
Telehealth medico legal aspects by dr alka mukherjee nagpur ms indiaalka mukherjee
The term telehealth includes a broad range of technologies and services to provide patient care and improve the healthcare delivery system as a whole. Telehealth is different from telemedicine because it refers to a broader scope of remote healthcare services than telemedicine. While telemedicine refers specifically to remote clinical services, telehealth can refer to remote non-clinical services, such as provider training, administrative meetings, and continuing medical education, in addition to clinical services. According to the World Health Organization, telehealth includes, “Surveillance, health promotion and public health functions.”
Telemedicine involves the use of electronic communications and software to provide clinical services to patients without an in-person visit. Telemedicine technology is frequently used for follow-up visits, management of chronic conditions, medication management, specialist consultation and a host of other clinical services that can be provided remotely via secure video and audio connections.
Insights about changes to the EU's MDR (Medical Device Regulations) by Ulf Grundmann, Partner, King & Spalding, August 17, 2020. Includes scope and definitions, classification and conformity assessment, placing a device on the EU marketin, UDI and EUDAMED, supply chain obligations, PMS, compliance and vigilance.
IMPACT OF APPLYING INTERNATIONAL QUALITY STANDARDS ON MEDICAL EQUIPMENT IN SA...ijcax
With the great development that, modern medical technology is witnessing today, medical devices and
equipment have become a basic pillar of any healthcare system in the world and cannot be dispensed with,
so we find competition between the major companies that manufacture medical devices and equipment
resulting in a huge variety of complex modern medical technologies. These medical devices and equipment
require high accuracy in manufacturing and packaging in addition to operation, maintenance, and followup, because any error in any of the previous stages will have bad consequences for the patients and the
health system, there are many accidents that have led to some deaths. Therefore, we find that many medical
device producers and medical companies in addition to health service providers seek to find systems and
protocols to reduce accidents resulting from medical devices. As a result, many systems have recently
appeared that seek to protect from the dangers of medical devices and equipment. This research aims to
conduct a study of the effects of international standards on the safety of medical devices and equipment
and reduce their risks. By counting the international standards in force in the Kingdom of Saudi Arabia
that are applied by the Saudi Food and Drug Authority, making questionnaires, and distributing them to
health service providers and regulatory bodies for medical devices and equipment, considering the data,
these data will be analysed and evaluated the effectiveness of quality systems and standards in maintaining
Effectiveness and quality of medical devices and equipment. The study will include governmental and
private health services sectors.
Title XIII of ARRA, also known as the Health Information Technology for Economic and Clinical Health Act (HITECH Act), reserves $22 billion to "advance the use of health information technology" -- in large part so the U.S. will be able to move to e-health records by President Obama\'s 2014 deadline.
1. LIFE SCIENCES
HEALTHCARE
1 | ARTHUR COX
Legal landscape struggles to
keep pace with the rise of
Telemedicine
Group Briefing
July 2016
Telemedicine encompasses a
wide variety of services such as
teleconsultation, telemonitoring and
telesurgery. Telemedicine can also
include remote consultation/e-visits
or video conferences between health
professionals and can be delivered
through various forms of IT systems
including mobile phone apps.
It is this complexity in delivery
that causes headaches for the legal
landscape due to the interplay between
the regulation of healthcare services,
medical devices, intellectual property
and data protection when offering
telemedicine services.
DEFINITION AND SCOPE OF TELEMEDICINE
Thenatureandscopeoftelemedicine
canbesomewhatdifficulttodefine.At
present,mostEuropeanUnionMember
Stateshavenotadoptedlegalinstruments
specificallyregulatingtelemedicine,
includingIreland.Therefore,thereis
nolegaldefinitionoftelemedicinein
Ireland.TheEuropeanCommission
definestelemedicineas“theprovision
ofhealthcareservices,throughtheuse
ofICT,insituationswherethehealth
professionalandthepatient(ortwo
healthprofessionals)arenotinthesame
location.Itinvolvessecuretransmission
ofmedicaldataandinformation,through
text,sound,imagesorotherforms
neededfortheprevention,diagnosis,
treatmentandfollow-upofpatients”.1
TheIrishHealthServiceExecutiveand
theDepartmentofHealthhavepublished
similardefinitions.2
It is worth noting that phrases such as
“telemedicine” “eHealth”, “telehealth”,
“telecare”, and “connected health” are
all used interchangeably in this context.
This has only added to the uncertainty
surrounding the scope and nature of
telemedicine services.
HEALTHCARE SERVICES
It is well established that telemedicine
is a service and as such falls under
the provisions of the Treaty on the
Functioning of the European Union
(i.e. Article 56 – freedom to provide
services). This includes the freedom for
citizens to receive health services from
another Member State, regardless of
how the service is delivered, i.e. through
telemedicine.
Directive 2011/24/EU which was
transposed in Ireland by the European
Union (Application of Patients’ Rights
in Cross-Border Healthcare) Regulations
1. Communication on telemedicine for the ben-
efit of patients, healthcare systems and society,
COM(2008)689
2. eHealth Strategy for Ireland
2015 endorses the right that all EU
citizens are entitled to receive health
services from another Member State,
regardless of how the service is delivered,
i.e. through telemedicine. The 2015
Regulations came into operation in
Ireland on 1 June 2014.
Patients have the right to be reimbursed
for the provision of cross-border health
services, which includes cross-border
telemedicine services. However,
reimbursement will occur only if the
telemedicine service falls within the
range of healthcare services to which
citizens are entitled in the Member State
of affiliation. Ireland is the Member
State of affiliation for persons insured
in Ireland who are receiving medical
treatment in another country.
Additionally, cross-border healthcare
is to be provided in accordance with
the legislation of the Member State
of treatment. For the purposes of the
2015 Regulations, the provision of
telemedicine is considered to have taken
place in the Member State in which the
healthcare provider is established.
One issue that arises in this regard
is the recognition of professional
qualifications. In Ireland, the Medical
Practitioners Act, 2007 (as amended)
requires all medical practitioners
practicing in Ireland to be on the register
This document contains a general summary of developments and is not a complete or definitive statement of
the law. Specific legal advice should be obtained where appropriate.
2. LIFE SCIENCES
HEALTHCARE
2 | ARTHUR COX LEGAL LANDSCAPE STRUGGLES TO KEEP PACE
WITH THE RISE OF TELEMEDICINE
maintained by the Medical Council
of Ireland. However, according to the
Directive and the 2015 Regulations, a
healthcare provider providing treatment
outside Ireland to patients in Ireland
is considered to be providing medical
treatment in the Member State in which
he or she is established. As such, the
medical practitioner would not need to
be registered with the Medical Council,
as he or she would not be providing
treatment in Ireland.
MEDICAL DEVICES LEGISLATION
The provision of telemedicine services
may also evoke the application of the
EU medical devices legislation, namely
Directive 93/42/EEC, Directive 98/79/
EEC and Directive 90/385/EEC. This is
due to the fact that manufacturers of
mobile health applications and devices
that support telemedicine services
must comply with multiple, and often
conflicting, regulatory requirements
promulgated by various regulatory
authorities.
Qualification of a device or software as
a medical device can trigger a number
of related regulatory requirements.
These include conducting clinical
investigations on the device, undergoing
a conformity assessment procedure and
CE marking the device.
Software embedded or incorporated
into medical hardware (e.g. software
that controls a CT scanner) is deemed
to be a medical device as it is an integral
part of the medical device. By contrast,
“standalone software” such as medical
health apps will be considered a
medical device only if it has a “medical
purpose”. Pursuant to Directive
93/42/EEC, standalone software has a
“medical purpose” if it is intended by
the manufacturer to be used for the
purposes 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; or
control of conception.”
The information in the instructions for
use, labelling and promotional materials
related to the device is important
when determining the manufacturer’s
intended purpose.
Software that monitors a patient and
collects information entered by the user,
measured automatically by the app or
collected by a point of care device may
qualify as a medical device if the output
affects the treatment of an individual. On
the other hand, software that provides
general information but does not
provide personalised advice, although
it may be targeted to a particular user
group, is unlikely to be considered a
medical device.
Manufacturers should consult the
various guidelines issued by the
regulatory authorities (including
the Irish Health Products Regulatory
Authority and the European
Commission) on the qualification and
classification of standalone software to
see if your software is in fact a medical
device or an in vitro diagnostic device.
DATA PROTECTION
The processing of personal data,
including personal health data, is
governed by the Data Protection
Directive 95/46/EC, which is transposed
in Ireland through the Data Protection
Acts 1988 and 2003. The processing of
sensitive information such as health
information is subject to stricter
requirements than other types of
personal data.
Directive 95/46/EC does not define
health data. However, according to the
Article 29 Working Party, which includes
representatives of the national data
protection authorities in the EU, health
data is not only data which is inherently
or clearly medical data, but also includes
raw sensor data which can be used in
combination with other data to draw
conclusions about the health status or
risk of a person, irrespective of whether
these conclusions are inaccurate,
illegitimate or inadequate. Thus, while
an app that tracks an individual’s steps
during a given day may not provide
significant substance with regard
to a person’s health, it may provide
information on a health condition when
analysed in combination with other
relevant personal information.
The processing of health data is
prohibited unless it can meet one of
the permitted exemptions in Directive
95/46/EC, which includes obtaining
the explicit consent of the relevant
individual. There are also other
requirements beyond the need to
obtain consent. All personal data must
be processed fairly and lawfully and
collected solely for specified, explicit
and legitimate purposes. Appropriate
technical and organisational measures
must be implemented to ensure the
security and confidentiality of the data.
It should be noted that the new EU
General Data Protection Regulation
(“GDPR”) will replace the existing
Directive 95/45/EC, with a more
harmonised approach to data protection
across the EU. As a regulation, the
GDPR will be directly applicable in the
member states, without the need for any
implementing legislation.
The new safeguards adopted by the
regulation will include the obligation
on controllers to introduce data
protection by design and default into
their processing systems. They will also
be obliged to produce a data protection
impact assessment (“DPIA”) where
proposed data processing is likely to
result in a high risk to the rights and
freedoms of individuals. It is important
to note that a DPIA is not mandatory
when doctors or healthcare professionals
process health data concerning their
patients. Additionally, the Irish Data
Protection Commissioner is permitted
to publish a list of processing operations
that do not require a DPIA. Many
organisations using health data may,
therefore, need to carry out DPIAs before
processing personal health data.
3. Dublin
+353 1 618 0000
dublin@arthurcox.com
Belfast
+44 28 9023 0007
belfast@arthurcox.com
London
+44 207 832 0200
london@arthurcox.com
New York
+1 212 782 3294
newyork@arthurcox.com
Silicon Valley
+1 650 943 2330
siliconvalley@arthurcox.com
arthurcox.com
LIFE SCIENCES
HEALTHCARE
3 | ARTHUR COX LEGAL LANDSCAPE STRUGGLES TO KEEP PACE
WITH THE RISE OF TELEMEDICINE
CONCLUSION
While telemedicine has obvious
benefits such as improving patient
care and healthcare system efficiency,
a fragmented legal landscape which
involves compliance with the various
different legal regimes discussed above
could hinder such benefits.
Companies offering telemedicine
services must keep this in mind and take
a holistic approach when navigating
the relevant legal and regulatory
requirements. Getting the key players
involved at this early stage will also
help identify any gaps in assessment.
As telemedicine is a moving target,
companies should also keep a dialogue
with the relevant regulatory authorities
to confirm whether the authorities are
drafting or preparing any guidance that
might be relevant.
ARTHUR COX - KEY CONTACTS
COLIN KAVANAGH
PARTNER
+353 1 618 0548
colin.kavanagh@arthurcox.com
CIARA FARRELL
SENIOR ASSOCIATE
+353 1 779 4368
ciara.farrell@arthurcox.com
OLIVIA MULLOOLY
ASSOCIATE
+353 1 618 1160
olivia.mullooly@arthurcox.com
ORLA KEANE
PARTNER
+353 1 618 0434
orla.keane@arthurcox.com