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Autoimmune Disease

InnoHEALTH magazine digital team — Tue, 05 Apr 2022 05:52:49 +0000

The immune system is a shield that guards against foreign invaders like bacteria and the virus. That’s the actual functioning of the immune system. When the immune system senses the existence of any foreign particle in the body, it immediately makes the antibodies to eliminate them. In autoimmune diseases, the immune system becomes a war zone. It misinterprets the body’s healthy nerves as foreign bodies and attacks them, reducing the ability to fight against infection and viruses.

One such condition is Guillain Barre Syndrome (GBS), one of the rarest autoimmune disorders that affect one in one lakh people in the USA. It affects the peripheral nervous system, severity ranging from mild weakness to depending on the life support system for breathing. Fortunately, there is 80% recovery after diagnosis and 5 – 10% delayed or incomplete recovery. It can affect anyone irrespective of the age group.

The reason for GBS onset is not known, but it is evident that the immune system attacks itself. The immune system produces antibodies when foreign bodies try to attack; these antibodies are nothing but the immune response towards the foreign bodies.

The reason for GBS onset is not known, but it is evident that the immune system attacks itself. The immune system produces antibodies when foreign bodies try to attack; these antibodies are nothing but the immune response towards the foreign bodies. But in the case of autoimmune disorder, when any viral or bacterial infection attacks the body, these bacteria or the virus start to resemble the nerves, and the immune system attacks the healthy nerves by mistake.

The onset of symptoms can be a very mild tingling sensation in the limbs to severe breathing difficulty. It starts from the lower body and moves up to the lungs leading to breathlessness, and sometimes occasionally, it starts from the upper body and moves down the lower body. The severity of the symptoms may vary from person to person, depending on the level of nerve damage. Weakness leading to restriction in the limb movement seeks immediate medical treatment.

Additional symptoms may include:

Severe pain in the nights
Blood pressure as a secondary symptom
Indigestion and loss of control over bladder
Sometimes coordination problems due to nerve damage which fails to send signals

The symptoms can get severe with the period if not treated immediately and sometimes may lead to paralysis, which can be life-threatening. When a person is affected with GBS, his nerves are damaged. Nerves are nothing but conducting wires. Nevers have axons covered with an insulating layer called myelin sheath that carries electric signals from the brain to the central and peripheral nervous system leading to immediate action or response towards the brains’ command.

In GBS patients, the myelin sheath is damaged and sometimes the entire axon results in complete failure in signal transmission, and the muscles start to lose their ability to respond to the brain’s command. Breathing can be weak, leading to a dependency on the life support system. Nerve damage may also cause abnormal transmission of signals that give spontaneous sensations called paresthesias, which is nothing but the tingling sensation that generates difficulty in limb movements.

The nerve damage occurs due to molecular mimicry theory, where the molecules of the nerve resemble the molecules of some microorganisms. Hence the microbes and the myelin sheath look similar, and when these microbes attack the immune system, they mistake the microbes for myelin sheath and attacks the healthy nerves treating them as foreign bodies. As a result, the immune system fails to recognise its nerves.

So the immune system basically produces antibodies for bacterial infection caused by Campylobacter jejuni, which attacks the axon in the motor nerves causing acute motor axonal neuropathy, which is one variant of GBS having acute paralysis, loss of reflexes but no sensory loss. This bacterial infection is caused by consuming contaminated food or uncooked food, especially meat.

This syndrome cannot be diagnosed in the initial stages due to the symptoms’ variation and intensity. Generally, the physician will examine and check if the symptoms are shown on both sides. Initially, the reflexes start to slow down in the joints. Sometimes, these reflexes are absent as the velocity of signal transmission slows down, which brings us to nerve conduction velocity tests the ability to transmit signals. So in GBS, the cerebrospinal fluid starts to change, and there has been some evidence stating that in GBS patients, the cerebrospinal fluid contains higher protein levels than usual. So the sample is collected from the lumbar region to examine the fluid.

Other diagnostic symptoms include

Abnormal sensation like tingling in the feet along with weakness
Diminished reflexes
High protein levels in cerebrospinal fluid

Treatment

Generally, short-term therapies can treat it to reduce the severity and lessen the recovery time. So the treatment includes Plasma exchange, and the other one is high dose immunoglobulin therapy (IVIg). Plasma exchange removes the blood with the help of a catheter via veins. Fresh plasma is extracted and returned to the patient. Plasma contains antibodies, so the PE removes the nerve-damaging plasma and reduces the severity of GBS.

Immunoglobulins are the proteins that produce antibodies against disease-causing microorganisms.

Immunoglobulins are the proteins that produce antibodies against disease-causing microorganisms. In IVIg therapy, the immunoglobulins are injected through intravenous infusion into the patient’s body. These immunoglobulins have been developed from healthy donors. Researchers have stated that this therapy shortens the recovery time, has fewer complications, and lowers the chances of the antibodies attacking its nerves by diluting with non-specific antibodies.

As the patients recover, they are moved to rehabilitation care for physical and mental health improvement. Physiotherapy for the muscles and limbs movement and therapy for mental health is a must to regain confidence during the recovery stage. It is a slow process, and the patient may tend to lose hope.

Composed by: “Sunayana is presently working as research Associate for Hetero Labs limited Hyderabad in formulation R&D injectables department (Non Onco).”

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CSIR-CDRI scientists develop RT-PCR kit for Omicron variant

InnoHEALTH magazine digital team — Thu, 27 Jan 2022 04:28:14 +0000

New Delhi, Jan 24 (India Science Wire): As the Coronavirus continues to mutate, it has become challenging to diagnose and treat different variants of concern. Some like the Omicron, though milder in symptoms and fatality, are a super spreader and are propagating like wildfire across the world.

Currently, detection of this variant depends upon tests like the S-gene dropout or by NGS (nextgen sequencing) of the whole viral genome. While the S-gene dropout method is not specific to pinpoint the type of variant, the NGS method has its limitations in terms of expense, turnaround, and the number of centres that can provide such service.

A team of scientists at CSIR-Central Drug Research Institute (CDRI), Lucknow, have developed an indigenous RT PCR Kit for the specific detection of the Omicron variant in collaboration with their industrial partner, Biotech Desk Pvt. Ltd., Hyderabad. The kit has been named INDICoV-Om^TM.

Dr. Atul Goel, the team leader said that the kit provides for quick and cost-effective detection of the Omicron variant. It can also be aligned for the detection of other emerging variants of COVID infection and other respiratory infections in the future. The kit has been tested and validated by Prof. Amita Jain in several Covid positive patient samples at King George Medical University, Lucknow.

Dr. Shradha Goenka, Managing Director, Biotech Desk Pvt. Ltd., said the kit was likely to be rolled out by mid-February. “We are working on regulatory approvals and the assembly of the kit. We are keeping our fingers crossed for an early release”, said Dr Goenka.

Prof. Tapas K. Kundu, Director CSIR-CDRI, said the Institute is rapidly gaining expertise in antiviral research for therapeutics and diagnostics to combat any kind of viral infections. The team led by Dr Atul Goel is fully prepared for the detection of broad spectrum and specific pathogenic viral infection. This kit for SARS-Cov-2 omicron diagnosis has been submitted to the Indian Council of Medical Research (ICMR) for validation and should be available for the people of the country soon.

The research team consisted of Dr. Niti Kumar, Dr. Ashish Arora, Ms. Surbhi Mundra, Ms. Varsha Kumari, Mr. Kundan Singh Rawat, and Ms. Priyanka Pandey, besides Dr. Goel.

ISW/SP/CSIR-CDRI/OMICRON/24/01/2022

Credits: India Science Wire

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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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