Today's Healthcare Technology and the Regulatory Standpoint

Akshay Anand
Akshay AnandRegulatory Affairs Professional em ITC Limited

Poster titled 'Today's Healthcare Technology and the Regulatory Standpoint' presented at 67th IPC (Indian Pharmaceutical Congress), held at Mysuru in December 2015.

Today's Healthcare Technology and the
Regulatory Standpoint
Akshay Anand M., Dr. M. P. Venkatesh, Dr. T. M. Pramod Kumar
II M.Pharm. (Pharmaceutical Regulatory Affairs), JSS College of Pharmacy, JSS University, Mysuru-570015
J-6
axayanand@gmail.com
*
Healthcare technology is a growing concern in the world today. The amalgamation of advancements in technology with healthcare surely demands inevitable
play of regulation on the same. This article throws light on regulation of healthcare technology which is a systematic application of knowledge in the form of
devices, drugs, procedures and systems developed to treat or cure a health condition, thereby improving the quality of life. Experiments like United States
Food and Drug Administration’s guidance document on mobile medical applications, draft on general wellness covering low risk device policies, European
Union’s data protection law expressed in device directives and its draft guidelines on mHealth and wearables have set a platform based upon which one to one
comparison has been made highlighting the adoption and strategies imposed on healthcare technology of the present day. This furnishes a near-clear picture
forregulatoryauthoritiestolestrunningandtocarefullychoosetowalkpromisingbettertomorrowinthevastfieldofhealthcaretechnology.
ABSTRACT
INTRODUCTION
Keywords: mHealth, Wearables, Healthcare Technology, FDA1741, 95/46/EC
Technology is a constantly evolving platform and healthcare
isn't new to its exposure. Medical devices are becoming the
matter of past with advancements in mHealth, wearables,
robotic diagnostics, implantable microchips, bionic limbs,
3D-printed organs. It is important for healthcare authorities
toregulatetheseadvancementstoensuresafetyforusers.
METHODS
Regulatory science or the drug regulatory affairs is a field that has practical limitations for
experimentation and the premise can be proven by the means of data driven original research and analysis
of data. The regulatory information was assessed from websites of the health authorities and the official
publications regarding the healthcare technology by the authorities. This mainly includes the FDA's
Guidance Document 1741 - Mobile Medical Applications; Guidance for Industry and Food and Drug
Administration Staff, Draft Guidance Document - General Wellness: Policy for Low Risk Devices, EU's
Data Protection Law expressed in 95/46/EC and the draft Green Paper on mHealth and wearables, TGA's
Therapeutic Goods Act where the Medical Technology Association of Australia (MTAA) interferes to set
the guidelines. A comparison has been made among these regulatory bodies highlighting the adaption and
strategiesimposedonthehealthcaretechnologyofthepresentday.
OBJECTIVES
The objective is to study the existing regulation for the
healthcare technology worldwide and to compare the same
within the regulated markets. Also, to focus on the
regulatory strategies employed for the technology and to
portray the impact generated on the technological
innovationinhealthcarefieldbytheregulatoryauthorities.
DISCUSSION
In today's healthcare scenario, technology finds its place everywhere right from patient data management
to the advanced diagnostics and treatment devices. The invasion of technology in healthcare has
deepened in the recent past with the adoption of desktop virtualization in hospitals witnessing a growth
of 44% in 2013 as per 'Imprivata' which ensures a secure data access for mobile clinicians. 'Juniper
Research' predicts that 3 million patients will be monitored via mobile networks by 2016. Wearable
sensors in healthcare are poised to enable inventions and predictive capabilities delivering billions in
savings and a truer sense of personal care. As per Tim Cook, CEO of Apple Inc., "The whole sensor field is
going to explode. It's a little all over the place right now, but with the arc of time it will become clearer". To
add to Tim Cook's words, the arc of time might be divided into two categories, the patient reach and the
regulatory aspects. When a technology is cleared on the regulatory pathway, it assures the safety of the
user and hence the user reach will be high. Not every market has a well-established regulations for
regulating the newer technology. As of 2015, USA is the only country to publish a guidance document
exclusively meant for regulating the innovative healthcare media including mHealth and wearables. The
European Union and Australia are yet to publish specialised guidelines and have stick to an amendment
approachwheretheyhavetweakedtheexistingmedicaldeviceregulations.
The approach of regulatory bodies have been different as stated
and the following table portrays the regulatory strategies
adopted by USA, EU and Australia for regulation of different
meansofinnovativetechnology.
Technology / Region USA (FDA) EU (EMA) Australia (TGA)
mHealth / Mobile
Medical Apps
FDA Guidance
document officially
issued in 2015.
Regulatory
approaches bind to
this guidance.
Draft guidance
issued. Currently
apps regulated as
Class I Medical
Devices which need
CE Marking.
Regulated by TGA
as medical devices if
the technology falls
under the definition
of 41BD of the
Therapeutic Goods
Act of 1989.
Wearables Gadgets
(Fitness Trackers /
Monitoring Devices)
Draft guidance,
‘General Wellness:
Policy for Low Risk
Devices’ issued, no
rigorous approach.
Draft Green Paper
and Data Protection
Law of 95/46/EC;
Class I
Classification and
CE marking.
Robotic Diagnostics
/ Medical Robots
Classified under
Class II medical
devices, need FDA
510(K) clearance.
Covered briefly by
93/42/EC Medical
device directive.
Also, 2005/50/EC,
89/686/EEC and
2006/95/EC apply.
No specific
regulations
available.
Bionic Limbs /
Prosthetic Devices
FDA review official
from 2014, covered
under medical
device guidance.
Brief guidance
available and bionic
limbs are marketed.
Implantables
(Microchips /
Sensors)
FDA Guidance
issued in 2014,
regulated as
tracking medical
devices.
Covered by
90/385/EEC Active
implantable medical
devices directive.
Classified as Class
III medical devices
and AIMDs.
Guidance available.
3D-printed organs /
Bioprinting
Relatively newer and advanced field, faces ethical and regulatory
debates. No regulations so far. Promises healthcare breakthrough
in the near future.
CONCLUSION
From the comparison, evident is the stance of authorities on the regulatory perspective for
technological advancements. USA's position as a pioneer in implementation of well-framed
regulatory pathways is notable. There is a necessity for stringent regulatory approaches
towardstheseforthepromisingfutureandtheimpacttheylevyoninnovation.
1. Brian D. Bollwage, JD, 'How will the FDA and the EU regulate my mobile
medicalapp?'AppliedClinicalTrials,February2015
2. Colin Lecher, 'The FDA doesn't want to regulate wearables, and device
makerswanttokeepitthatway'TheVergeMagazine,June2015
3. Victoria Hordern, 'Will the New EU Data Protection Regulation Facilitate
HealthcareInnovation?'ChronicleofDataProtection,January2015
REFERENCES
T h e a u t h o r s a r e
thankful to JSS College
of Pharmacy and JSS
University, Mysuru for
the encouragement
andsupport.
ACKNOWLEDGEMENTS
Accredited ‘A’ Grade by NAAC
Poster presented at the 67th IPC held at JSS University, Mysuru, Karnataka during 19-21 December 2015.

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Today's Healthcare Technology and the Regulatory Standpoint

  • 1. Today's Healthcare Technology and the Regulatory Standpoint Akshay Anand M., Dr. M. P. Venkatesh, Dr. T. M. Pramod Kumar II M.Pharm. (Pharmaceutical Regulatory Affairs), JSS College of Pharmacy, JSS University, Mysuru-570015 J-6 axayanand@gmail.com * Healthcare technology is a growing concern in the world today. The amalgamation of advancements in technology with healthcare surely demands inevitable play of regulation on the same. This article throws light on regulation of healthcare technology which is a systematic application of knowledge in the form of devices, drugs, procedures and systems developed to treat or cure a health condition, thereby improving the quality of life. Experiments like United States Food and Drug Administration’s guidance document on mobile medical applications, draft on general wellness covering low risk device policies, European Union’s data protection law expressed in device directives and its draft guidelines on mHealth and wearables have set a platform based upon which one to one comparison has been made highlighting the adoption and strategies imposed on healthcare technology of the present day. This furnishes a near-clear picture forregulatoryauthoritiestolestrunningandtocarefullychoosetowalkpromisingbettertomorrowinthevastfieldofhealthcaretechnology. ABSTRACT INTRODUCTION Keywords: mHealth, Wearables, Healthcare Technology, FDA1741, 95/46/EC Technology is a constantly evolving platform and healthcare isn't new to its exposure. Medical devices are becoming the matter of past with advancements in mHealth, wearables, robotic diagnostics, implantable microchips, bionic limbs, 3D-printed organs. It is important for healthcare authorities toregulatetheseadvancementstoensuresafetyforusers. METHODS Regulatory science or the drug regulatory affairs is a field that has practical limitations for experimentation and the premise can be proven by the means of data driven original research and analysis of data. The regulatory information was assessed from websites of the health authorities and the official publications regarding the healthcare technology by the authorities. This mainly includes the FDA's Guidance Document 1741 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff, Draft Guidance Document - General Wellness: Policy for Low Risk Devices, EU's Data Protection Law expressed in 95/46/EC and the draft Green Paper on mHealth and wearables, TGA's Therapeutic Goods Act where the Medical Technology Association of Australia (MTAA) interferes to set the guidelines. A comparison has been made among these regulatory bodies highlighting the adaption and strategiesimposedonthehealthcaretechnologyofthepresentday. OBJECTIVES The objective is to study the existing regulation for the healthcare technology worldwide and to compare the same within the regulated markets. Also, to focus on the regulatory strategies employed for the technology and to portray the impact generated on the technological innovationinhealthcarefieldbytheregulatoryauthorities. DISCUSSION In today's healthcare scenario, technology finds its place everywhere right from patient data management to the advanced diagnostics and treatment devices. The invasion of technology in healthcare has deepened in the recent past with the adoption of desktop virtualization in hospitals witnessing a growth of 44% in 2013 as per 'Imprivata' which ensures a secure data access for mobile clinicians. 'Juniper Research' predicts that 3 million patients will be monitored via mobile networks by 2016. Wearable sensors in healthcare are poised to enable inventions and predictive capabilities delivering billions in savings and a truer sense of personal care. As per Tim Cook, CEO of Apple Inc., "The whole sensor field is going to explode. It's a little all over the place right now, but with the arc of time it will become clearer". To add to Tim Cook's words, the arc of time might be divided into two categories, the patient reach and the regulatory aspects. When a technology is cleared on the regulatory pathway, it assures the safety of the user and hence the user reach will be high. Not every market has a well-established regulations for regulating the newer technology. As of 2015, USA is the only country to publish a guidance document exclusively meant for regulating the innovative healthcare media including mHealth and wearables. The European Union and Australia are yet to publish specialised guidelines and have stick to an amendment approachwheretheyhavetweakedtheexistingmedicaldeviceregulations. The approach of regulatory bodies have been different as stated and the following table portrays the regulatory strategies adopted by USA, EU and Australia for regulation of different meansofinnovativetechnology. Technology / Region USA (FDA) EU (EMA) Australia (TGA) mHealth / Mobile Medical Apps FDA Guidance document officially issued in 2015. Regulatory approaches bind to this guidance. Draft guidance issued. Currently apps regulated as Class I Medical Devices which need CE Marking. Regulated by TGA as medical devices if the technology falls under the definition of 41BD of the Therapeutic Goods Act of 1989. Wearables Gadgets (Fitness Trackers / Monitoring Devices) Draft guidance, ‘General Wellness: Policy for Low Risk Devices’ issued, no rigorous approach. Draft Green Paper and Data Protection Law of 95/46/EC; Class I Classification and CE marking. Robotic Diagnostics / Medical Robots Classified under Class II medical devices, need FDA 510(K) clearance. Covered briefly by 93/42/EC Medical device directive. Also, 2005/50/EC, 89/686/EEC and 2006/95/EC apply. No specific regulations available. Bionic Limbs / Prosthetic Devices FDA review official from 2014, covered under medical device guidance. Brief guidance available and bionic limbs are marketed. Implantables (Microchips / Sensors) FDA Guidance issued in 2014, regulated as tracking medical devices. Covered by 90/385/EEC Active implantable medical devices directive. Classified as Class III medical devices and AIMDs. Guidance available. 3D-printed organs / Bioprinting Relatively newer and advanced field, faces ethical and regulatory debates. No regulations so far. Promises healthcare breakthrough in the near future. CONCLUSION From the comparison, evident is the stance of authorities on the regulatory perspective for technological advancements. USA's position as a pioneer in implementation of well-framed regulatory pathways is notable. There is a necessity for stringent regulatory approaches towardstheseforthepromisingfutureandtheimpacttheylevyoninnovation. 1. Brian D. Bollwage, JD, 'How will the FDA and the EU regulate my mobile medicalapp?'AppliedClinicalTrials,February2015 2. Colin Lecher, 'The FDA doesn't want to regulate wearables, and device makerswanttokeepitthatway'TheVergeMagazine,June2015 3. Victoria Hordern, 'Will the New EU Data Protection Regulation Facilitate HealthcareInnovation?'ChronicleofDataProtection,January2015 REFERENCES T h e a u t h o r s a r e thankful to JSS College of Pharmacy and JSS University, Mysuru for the encouragement andsupport. ACKNOWLEDGEMENTS Accredited ‘A’ Grade by NAAC Poster presented at the 67th IPC held at JSS University, Mysuru, Karnataka during 19-21 December 2015.