Medical Equipment Archives - InnoHEALTH magazine

Furthering the Medical Devices Sector in India

InnoHEALTH magazine digital team — Fri, 24 Jun 2022 08:57:06 +0000

The medical devices segment is diverse, creative, and dynamic sector that includes a wide range of products such as implants, surgical instruments, medical equipment, In-vitro diagnostic reagents, and consumables. It is an essential part of the healthcare system for diagnosis, treatment, and prevention of health issues. The Indian medical devices market is currently estimated to be $11 bn, with global market share of nearly 1.5% . India is Asia’s 4^th biggest market and ranks in top 20 global medical devices markets. It is reported that the Indian medical devices sector is at its nascent stage and import centric, around 80% of medical devices are imported to meet the domestic requirements, majority of them come from the US, China, and Germany. Despite high import dependency, the Indian medical devices sector is expected to grow at 7 % CAGR during 2021 to 2025 and is projected to observe the rapid growth in the Asia Pacific market.

The accelerated growth is anticipated due to concurrent reasons such as rising demand of devices because of global pandemic, rising prevalence of chronic diseases, and elderly population which is expected to grow by 41% in 2031 compared to 2021. To reduce the import dependency and satisfy the rising demand of medical devices, a comprehensive, and carefully devised strategy is required, which shall assist in achieving the fundamental objectives such as accessibility, affordability, quality, in-house manufacturing and skilled manpower.

The medical devices parks were envisaged by allocating 400 crores for developing the medical devices, research facilities and skilled manpower.

The various government initiatives

Although 100 percent FDI through automatic route in medical devices was allowed in 2014, tangible attention of policy makers and bureaucrats appeared only in the last two or three years during and post-pandemic. To strengthen the medical devices sector, the government provided the financial support of 25 crore to Andhra Pradesh MedTech Zone (AMTZ) for a common facility centre. Subsequently, to improve manufacturing in cancer/radiotherapy, imaging devices, renal and cardio-respiratory devices and implants sectors, the production linked incentives scheme for medical devices was initiated in 2020, with an amount of 3,420 crore. Further, the medical devices parks were envisaged by allocating 400 crores for developing the medical devices, research facilities and skilled manpower. By introduction of the medical devices rule 2017, which categories the medical devices in four classes, the quality and efficacy was inducted in this sector.

Moreover, the national pharmaceutical pricing authority swung in action for price capping of knee implant, stents, oxygen concentrator and point of care devices (POC) to reduce the dealer’s margin. To address the rising price of drugs, the government opened 8604 affordable outlets (Jan Aushadhi Kendras) which offer 1451 drugs and 240 types of surgical supplies. Another step towards Universal Health Coverage (UHC), The initiative of the Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) was pioneered by providing the health insurance of ₹ 5 lakhs per family per year, which covers approximately 50 crore Indian poor and vulnerable families. The forenamed initiatives deserve the praise for notable work by the government, but there is still a necessity to advance medical devices sectors to achieve the vision of affordable and quality care to every stratum of the society.

Areas of improvement and suggestions

Despite various schemes initiated by the government, there is a necessity for a comprehensive and clear roadmap for accelerated and continuous growth in the sector. The urge for improvements in the sector is further stressed by the diversity in the medical devices product segment which demands the wide range of interventions in different areas as underscored below.

Medical devices regulation: The single window online portal for efficient management of information associated with medical devices is essential. The online portal should allow ease in medical device registration, obtaining import and manufacturing licensing, clearance for clinical investigation to all the stakeholders like Co-WIN portal used for vaccination drive.

Research and Development (R & D) funding: The allocation of dedicated funds to encourage joint research with industry, academic and start-ups is much entailed. The fund should be disbursed for building contemporary laboratories for various evaluations, implant and instruments testing, animal studies, equipment testing etc. for R & D activities. These well-equipped laboratories could lead to enhanced research-oriented collaboration, partnerships and innovation in the domestic medical devices sector.

Price regulation of medical devices: The projected Indian annual per capita income in 2022 is ₹ 1,78,944 ($2,357.643) which translates ₹14,912 per month. The per month income for quality health services to common people is surely less, thus price regulation of medical devices and hospital charges could play an important role in offering affordable medical devices to all. However, careful understanding of medical devices and well devised strategy for price regulation will be required to maintain stability in the medical devices segment.

The various media reports stressed the shortage of beds in health care centres, which left patients unattended for a long time. This insinuated the need for a good physical foundation for health services and healthcare research for better management and treatment of diseases.

Healthcare Infrastructure: The highly infectious COVID-19 virus has created panic in the healthcare community and its deleterious episodes are continuing. On other hand it has emphasised the need for infrastructure requirements. The various media reports stressed the shortage of beds in health care centres, which left patients unattended for a long time. This insinuated the need for a good physical foundation for health services and healthcare research for better management and treatment of diseases. Thus, the need for contemporary healthcare infrastructure is essential, which may also attract the domestic manufactures to invest in medical devices sectors.

Promoting the collaboration: The idea of industrial cluster near to all academic Institutions, could provide the essential environment for industrial collaboration, The global giant in medical devices technology such as Medtronic, Stryker, GE Healthcare, Philips, and Medtronic shall be encircled in this type of collaboration, it can be easily done since most of them already have centres in India. The triple helix model, commonly used in western countries, shall be tried in this collaboration initiative, where government, industry and Institutes would interact for improvement in the domestic medical devices segment.

Innovation parks: The promotion of the ecosystem that houses the network of institutions, start-ups, clinical setting, funding agencies is much needed. This type of ecosystem is called innovation parks; the medical devices parks should be initiated to provide the impetus to scale up the production, encourage the research to market translation and quality medical devices. These parks shall further have strong association with the Ministry of Human Resource Development to make necessary corrections in National Education Policy 2022, by designing proper course work to meet the domestic medical device industry requirements.

Creating centres of excellence: The further boost in creating centres of excellence at reputed institutes would attract world class faculties to engage them in medical devices which are fit for India. These centres shall be further strengthened to drive the role in product development, validation, certification, promote the safety and efficacy and use of latest technology such as Internet of Things (IoT), Robotics, Telemedicine, Artificial Intelligence (AI) etc in the medical devices sector.

Trained Human Resource: As pre survey from AMTZ the half of the workforce in the medical devices sector are unskilled, signaling the need for skill development programs in this sector. The National Institutes for medical devices like IITs, NITs and IISc could be envisaged. These institutes shall provide training, internship, and hands -on experience in medical devices. Further, association with private players shall be encouraged for research and training funding. The course curriculum in these Institutes shall be drafted such that it brings doctors, technicians, service engineering, scientists, and engineers together like Clinical Engineering, a joint initiative by three Institutions namely IIT Madras, SCTIMST and CMC Vellore to improve the skills in the domain.

Patenting is the formal way to protect innovative ideas.

IP (intellectual property): Patenting is the formal way to protect innovative ideas. Intellectual property right offers various advantages such as, competitive advantages against the established competitors, prevents ideas from theft, and signals to investors about the new technology. Patenting in the Indian medical devices sector shall be encouraged for continuous and stable growth in the sector.

Custom Duty: It is a long pending request from the Indian Medical devices industry to increase the custom duty on imported medical devices. The demand is to increase the custom duty from 0 to 7.5 % to 15% and reduce the GST from 18% to 12%. The call on the request shall be considered after proper evaluations, since on one side it will ease the entry of local medical device manufacturers in the market but on other side it will lead to deficiency of quality and innovative product in market.

Acceptance of personalized treatment: Personalized care often called precision medicine is tailor-made treatment to patients based on their molecular profiling. It is an emerging and exciting treatment approach which envisages an important role in preventing and predicting diseases and educates patients to get the right treatment. There shall be a policy to promote such patient centric treatment initiatives within the country, which will contribute to the growth in the medical devices segment since personalized medicine has over-reliance on diagnostic devices.

The aforementioned suggestions are specific to build a strong foundation for the Indian medical devices sector. These are a few steps to reduce import dependency and realize the self-reliant India. If these areas are stressed for the next decade, India could become the global supplier in medical devices from the status of importer.

Composed by: “Er. Arvind Kumar Prajapati is a Scientist/Engineer at Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Department of Science and Technology, Government of India, Trivandrum, Kerala. He has been closely working in design, development, testing and validation of Knee, Hip, and Spine implants and instruments.”

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The Vulnerability of Medical Institutions to Cyber Attacks

InnoHEALTH Magazine — Mon, 24 Jun 2019 10:39:58 +0000

McAfee’s researchers were able to modify the vital sign data in real-time providing false information to medical personnel by switching the heartbeat records from 80 beats a second to zero within five seconds. You would have woken up to news that Medstar patient records’ database was subject to ransom ware cyber attack and was asked to pay bitcoins. Unfortunately, the hospital did not have backup of medical records and in some cases, they had to turn away the patients. These incidents, unfortunately, are not stray incidents.

There are various technologies converging and a rapid increase in machine-to-machine communications. It is predicted that by 2025, most hospitals will have the ability to network connect more than 90% of their devices. However, many hospitals are yet to make their data security systems extremely robust. Data privacy and data security are the two important pillars that need urgent consideration. Just as financial data is loved by the cyber criminals, so is health data becoming a gold-mine with the cyber offenders. Specially so when the hospitals are run on legacy systems and there is no dedicated framework or surveillance on their own data.

Personally, identifiable data is an indicator of an individual, such as name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person.Several cyberattacks on medical institutions are initiated to extract the electronic health records (EHRs) of patients. These EHRs may contain their personal health information, medical history, diagnosis codes, billing information, etc., which can be exploited by the cyber offenders in various manners, for instance to get ransom from the medical institutions or to create fake IDs to buy medical equipment(s) or medication which can be resold or exclusively sold on prescription.

Take this example. On 12 May 2017, a global ransomware attack, known as WannaCry affected more than 200,000 computers in at least 100 countries. The ransomware attack also affected 80 out of 236 trusts (medical institutions under NHS) and further 603 primary care and other National Health Service (“NHS”) organisations were infected with the ransomware virus including 595 general practitioners. The trusts which were affected with WannaCry ransomware faced issues like patient appointments being cancelled, computers being locked out, diversion of patients from accidents and emergency departments, etc.

As reported in the investigation report on the WannaCry ransomware attack on NHS, published by the National Audit Office (“NAO”, an independent parliamentary body in the United Kingdom), all NHS organisations infected with the WannaCry virus had unpatched or unsupported Windows operating systems. NHS Digital (a national provider of information, data and IT systems for commissioners, analysts and clinicians in health and social care in England) informed the NAO that the ransomware spread via the internet, including through the N3 network (the broadband network connecting all NHS sites in England), though there were no instances of the ransomware spreading via NHSmail (the NHS email system).

In India, as reported by multiple news agencies, last year in the month of June, the Mahatma Gandhi Memorial (a trust-run hospital) hospital, Mumbai (MGM Hospital) was affected by a similar cyber-attack where the hospital administrators found their systems locked and noticed an encrypted message by the attackers demanding ransom in Bitcoins to unlock it. It was reported that the MGM Hospital had lost 15 days’ data related to billing and patients’ history, though the hospital didn’t face any financial loss.

Once these cyber offenders have access to the EHRs, they hold the systems of the medical institutions hostage for ransom, by encrypting all the systems completely inaccessible and unusable for the victimised medical institutions. The vulnerability to such cyberattacks may account to various reasons, such as outdated digital infrastructure, medical personnel unaware or untrained about cyberattacks. Cyber offenders may gain access to medical institutions’ systems through various ways and sometimes as simple as (a) using a USB drive; (b) exploiting vulnerable or expired software, (c) stealing medical personnel’s mobile devices, (d) hacking email or (e) phishing, etc. It is time that our healthcare providers upgrade their technologies, networks, and understanding on this subject.

Regulatory bodies across the world have suggested / adopted guidelines and cybersecurity processes and controls which help the medical institutions to mitigate cyber risks and vulnerabilities. In this article, we will be primarily focusing on various safeguards and standards put in place by the European Union and India to deal with such cyberattacks.

SCENARIO IN EUROPE

As a part of the EU cybersecurity strategy, the European Commission standards to ensure necessary adopted the EU Network and Information Security Directive (“NIS Directive”) on 6 July 2016 and it came into force in August 2016. As the NIS Directive is an EU directive, every member state had to adopt a national legislation which would transpose the NIS Directive by 9 May 2018 and identify operators of essential services under the transposed law by 9 November 2018.

The NIS Directive has three major parts to it (a) national capabilities, (b) crossborder collaborations and (c) national supervision of the critical sectors including health.

(a) National Capabilities: The NIS Directive mandates every member state of the EU to have certain cybersecurity capabilities, e.g., it is a mandate for every member state to have a national Computer Security Incident Response Team (“CSIRT”).

(b) Cross Border Collaborations: The NIS Directive encourages collaborations between EU member states like the EU CSIRT network, the NIS cooperation group, ENISA etc.

(c) National Supervision of Critical Sectors: As per the NIS Directive, every member state shall supervise the cybersecurity of critical market sectors in their respective country including health sector.

Further, as a part of the NIS Directive the NIS cooperation group through ENISA has developed guidelines regarding (a) identification criteria of cyberattacks, (b) incident notification, (c) security requirements for Digital Signal Processors (DSPs), (d) mapping of operators of essential services (OES) security requirements for specific sectors including health and (e) audit and self-assessment frameworks for OESs and DSPs.

With a view to prescribe certain standards of safety and quality, three recognised EU standards organisations namely (a) the European Committee for Standardisation (CEN), (b) the European Committee for Electro-technical Standardization (CENELEC) and, (c) the European Telecommunications Standards Institute (ETSI) were set up. By setting common standards across EU, CEN, ETSI and CENELEC ensure protection of consumers, facilitate cross-border trade, ensure interoperability of goods/ products, encourage innovation and technological development, and include environmental protection and enable businesses to grow.

The General Data Protection Regulations (“GDPR”) specifically define ‘data concerning health’, ‘genetic data’ and ‘biometric data’ and regards them as ‘special category of data’. This means that parties who are processing special category of data shall comply with additional higher safeguards and process it legitimately. Recital 53 of the GDPR states that special categories of personal data which merit higher protection should be processed for health-related purposes only.

THE INDIAN SCENARIO

Personal medical/health information in India is regarded as sensitive personal information as per the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal data or Information) Rules, 2011 (“Rules”).

The Indian legislature took an important step for addressing issues relating to cybersecurity when it amended the Information Technology Act, 2000 in 2008, through which they established an Indian Computer Emergency Response Team (CERT), a national agency for incident response. CERT is primarily responsible for handling cybersecurity incidents occurring in India and analysing information related to cybercrimes, but among other things CERT is also indulged in issuing guidelines, advisories, vulnerability notes and white papers relating to information security practices, procedures, prevention, response and reporting of cyber incident.

CERT-India has been entrusted with performing the following main functions (a) collecting, analysing and disseminating of information on cyber incidents, (b) forecasting and giving alerts on cybersecurity incidents, (c) laying down emergency measures for handling cyber security incidents, (d) coordinating cyber incident response activities, (e) issuing guidelines, advisories, vulnerability notes and white papers relating to information security practices, procedures, prevention, response and reporting of cyber incidents, and (f) performing any other functions relating to cybersecurity as may be prescribed.

CERT-India in the last five years or so has focused on making various institutions who are highly dependent on cyber/digital networks, i.e. are ‘cyber resilient’. Being cyber resilient allows these institutions to effectively anticipate the various threats and figure out the mechanisms of dealing with the cyberattacks. Anticipate, withstand, contain and recover are the 4 main contours of being cyber resilient.

Anticipate: Maintain a state of informed preparedness to forestall compromises of mission/ business functions from adversary attacks
Withstand: Continue essential mission/business functions despite successful execution of an attack by an adversary
Contain: Localize containment of crisis and isolate trusted systems from untrusted systems to continue essential business operations in the event of cyberattacks
Recover: Restore mission/business functions to the maximum extent possible subsequent to successful execution of an attack by an adversary
Evolve: To change missions/business functions and/or the supporting cyber capabilities, to minimize adverse impacts from actual or predicted adversary attacks

To strengthen the framework and ensure that reasonable security practices and procedures are followed, the Department of Information Technology introduced certain rules. The rules require each and every corporate body including medical institutions who collect sensitive personal information to have security measures as documented in their security policy/programme which is considered to be a reasonable security practice, keeping in mind the nature of their business and considering the fact that they are collecting sensitive personal information. One such international standard as recommended under the Rules is the IS/ISO/IEC 27001.

Taking a step further, the Ministry of Health and Welfare has introduced a draft bill for Digital Information Security in Healthcare Act (“DISHA”). One of the key purposes of DISHA is to ensure reliability, data privacy, confidentiality and security of digital health data. DISHA prescribes that the storage of digital health data so collected would be held in trust for the owner and the holder of such data would be considered as the custodian of data, thereby making such holder responsible to protect privacy, confidentiality and security of data.

To bring it all together:

Majority of the cyberattacks reported worldwide are caused due to reasons which sometimes are trivial and perhaps ignored more often, such as outdated Windows operating system patch, lack of proper antivirus or reasons such as phishing, lack of awareness among the people about cybersecurity, etc.

The EU, through GDPR has made data security an integral part of law and India is taking strong steps to set up a robust data protection and data security law. Various regulations, programmes, codes, standards, etc., discussed in this article are some key indicate steps that can be implemented.

Law is just one part to solve the issue. The real question is who is responsible for safety of our personal data, commercial data, data assets, etc.? We secure our houses with a lock, burglar alarms, video cams because the house owner wants to protect it. Similarly, individuals, organizations, healthcare personnel, hospitals and other institutions who collect health data for multiple reasons should be aware of various cyber-threats and must take steps to safeguard their networks and systems from such threats.

About the author:

Sharda Balaji is the founding partner of NovoJuris Legal, and along with being a qualified lawyer is also a company secretary and has been at the core of evolution of technology and IT laws in India.

Manas Ingle is a legal associate at NovoJuris Legal and works as a technology lawyer, where he deals with various legal projects relating

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Top 5 Latest Healthcare Innovations

InnoHEALTH Magazine — Mon, 17 Dec 2018 07:03:05 +0000

1. Air Ambulance India

Two engineering students, Goutham Sharma, and Jervis Anthony have recently designed and developed a highspeed hybrid unmanned aerial vehicle (UAV) which can surpass traffic and obstacles to serve as an air ambulance for patients who need intensive medical aid and emergency medical services. The device is equipped with emergency medical equipment like automated external defibrillators, automated blood pressure apparatus, and other emergencies medical equipment. Their aim is to provide timely medical access to patients. The device can carry a person weighing 50kg but in a sleeping position due to the present design constraint. www.thebetterindia.com/132598/

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