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		<title>How Crucial is DISHA Act for Healthcare Industry?</title>
		<link>https://innohealthmagazine.com/2018/others/policy/disha-act-for-healthcare-industry/</link>
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		<dc:creator><![CDATA[InnoHEALTH Magazine]]></dc:creator>
		<pubDate>Mon, 17 Dec 2018 08:56:22 +0000</pubDate>
				<category><![CDATA[Policy]]></category>
		<category><![CDATA[banking]]></category>
		<category><![CDATA[Clinical Establishment Act Standards]]></category>
		<category><![CDATA[CRUD]]></category>
		<category><![CDATA[Data]]></category>
		<category><![CDATA[data breach]]></category>
		<category><![CDATA[data privacy]]></category>
		<category><![CDATA[data safe]]></category>
		<category><![CDATA[database]]></category>
		<category><![CDATA[decrypt]]></category>
		<category><![CDATA[digital gealth]]></category>
		<category><![CDATA[digital health record]]></category>
		<category><![CDATA[Digital Information Security]]></category>
		<category><![CDATA[disasters]]></category>
		<category><![CDATA[DISHA]]></category>
		<category><![CDATA[Disha act]]></category>
		<category><![CDATA[Electronic Health Record]]></category>
		<category><![CDATA[emergencies]]></category>
		<category><![CDATA[encrypt]]></category>
		<category><![CDATA[epidemics]]></category>
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		<category><![CDATA[health information]]></category>
		<category><![CDATA[healthcare data]]></category>
		<category><![CDATA[healthcare IT company]]></category>
		<category><![CDATA[IBM report]]></category>
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		<category><![CDATA[security]]></category>
		<category><![CDATA[Software]]></category>
		<category><![CDATA[Stakeholder]]></category>
		<category><![CDATA[Statistics]]></category>
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		<category><![CDATA[Technology]]></category>
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					<description><![CDATA[<p>The question we need to ask ourselves is that Why DISHA is the need of the hour? Why we need to safeguard the electronic health record in hospitals?</p>
<p>The post <a href="https://innohealthmagazine.com/2018/others/policy/disha-act-for-healthcare-industry/">How Crucial is DISHA Act for Healthcare Industry?</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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	<p style="text-align: justify !important;">&#8220;A journey of a thousand miles begins with a single step.&#8221; <strong><a href="https://innohealthmagazine.cominnovatiocuris/disha-act/">The Digital Information Security in Healthcare Act (&#8216;DISHA&#8217;)</a></strong> is that firm first step taken by the Indian Government in the long journey to secure the healthcare data of patients in India. The question we need to ask ourselves is that Why DISHA is the need of the hour? Why do we need to safeguard the electronic health record in hospitals?</p>
<p style="text-align: justify !important;">The draft of the act was made public in November 2017 by Ministry of Health and Family Welfare. The word ‘Disha’ means direction, the GoI has taken the first step in the direction of safeguarding the digital health record. For this <a href="http://www.innovatiocuris.com">InnovatioCuris</a> has also taken the first step towards having a concrete discussion about ‘Challenges in the implementation and opportunities for making health sector DISHA and data protection ready’. There were panelists from various renowned government, private hospitals, and healthcare IT firms.</p>
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	<p style="text-align: justify !important;">The first session was about the ‘Challenges in the implementation of DISHA’. The panelists were happy that InnovatioCuris has taken an initiative to critically discuss the challenges a hospital will face once the act becomes the law. All the panelists agreed that the act lacks various aspects. Few concerns that bother the clinicians are, that who will give the consent if the patient is unconscious.</p>
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	<p style="text-align: justify !important;">The ambulances have the capability that it sends the health records from the ambulance to hospital before the patient reaches the hospital for doctors to study the emergency cases. In this scenario, what should be done if a patient denies the consent for sharing the data at a later stage? Should the clinical establishments discard the already shared health record or should they handover the same to the owner (in this case, patient) or what should be done. There are no set protocols defined in the act for such cases.</p>
<p style="text-align: justify !important;">A question was put forward, does the patient has the authority to edit their health record, or can they view, who have seen their health record. A healthy discussion took place where we got to know that citizens of Estonia have chip cards, where one can see their health record and can also see the logs of who has accessed their health record. This made us realize, that India as a nation state can use Aadhar card as a mechanism, where we can log in into a portal and get to see health records.</p>
<p style="text-align: justify !important;">The third challenge that came forward was interoperability of health records. As the record lies with the custodian, not the patient, editing and viewing of it can be done by the clinical establishments. The health record can be shared by the clinical establishments to another, but there is no standard on how to transfer it. Data integrity is a point of concern, which is not mentioned in the act.</p>
<p style="text-align: justify !important;">One of the challenges that came into light was according to ‘Clinical Establishment Act Standards for Hospital<strong><a href="http://clinicalestablishments.gov.in/WriteReadData/147.pdf" target="_blank" rel="noopener noreferrer">[2]</a></strong>’ the hospital has to keep health information and statistics in respect of national programmes, notifiable diseases, and emergencies/disasters/epidemics and furnish the same to the district authorities in the prescribed formats and frequency. The question is what if the patient does not give consent. The proposed act should have a provision where the clinical establishments are liable to take the health data.</p>
<p style="text-align: justify !important;">As we have unstructured healthcare facilities in India, the act should also empower the clinical establishments by various means to keep the data safe. As of now the DISHA is a proposed act, not a law and has lots of loopholes. It also lacks in many aspects discussed earlier. This is just a start and the government should take necessary steps to improve it.</p>
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	<p style="text-align: justify !important;">The second panel discussed on ‘Opportunities for making health sector DISHA and data protection ready’. The panelist consisted of CIO of path labs, owners of healthcare IT firms, who shared relevant thoughts and comments. The panel started the discussion on why do we need the act and what are the benefits of the act. Panelist were grateful to the government to bring the act. They told that the clinical establishments will take steps to increase the safety of the health record.</p>
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	<p style="text-align: justify !important;">The gaps in the technology for generation, storage and transmission will be lowered down. Sectors such as banking, financing and insurance have structured their data, but this lacks in healthcare. Detailed scope of security features are missing from the act, this would help the companies to design the software from the ground up by using security as an important consideration.</p>
<p style="text-align: justify !important;">The imminent threat is in the software which are already in place and have not been patched or the system has not been upgraded. The good news is that many have an audit trail in built in their system, which track any CRUD(creation, read, update, delete) of the records. The discussion contributed a fruitful thought: Data at rest is not encrypted. The question that arises is what is preventing the healthcare IT companies to encrypt the data at rest.</p>
<p style="text-align: justify !important;">One of the challenge in the DISHA is that, the owner of the data must be informed of any breach of the privacy or confidentiality of their digital health record within three days. But according to IBM report it takes on an average of 197 days to detect a breach<strong>[1]</strong>. How can the Healthcare IT companies safeguard the health record and let the owner know about the breach. The solution is to encrypt the tables in the database, but that might hamper the performance.</p>
<p style="text-align: justify !important;">It is a huge opportunity for the stakeholder to bring standards in the act. DISHA might have only completed its first round of comments from the public and stakeholders, it can be expected that the revisions made based on the feedback will churn out a more refined version of the act. In any case, it is evident from the draft that the government has really pushed to provide additional security, privacy and confidentiality for individuals, with respect to their digital health record.</p>
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<p>The post <a href="https://innohealthmagazine.com/2018/others/policy/disha-act-for-healthcare-industry/">How Crucial is DISHA Act for Healthcare Industry?</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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		<title>Software as Medical Device</title>
		<link>https://innohealthmagazine.com/2018/issues/software-as-medical-device/</link>
					<comments>https://innohealthmagazine.com/2018/issues/software-as-medical-device/#comments</comments>
		
		<dc:creator><![CDATA[InnoHEALTH Magazine]]></dc:creator>
		<pubDate>Wed, 09 May 2018 05:23:22 +0000</pubDate>
				<category><![CDATA[Issues]]></category>
		<category><![CDATA[AI]]></category>
		<category><![CDATA[Artificial Intelligence]]></category>
		<category><![CDATA[CDSCO]]></category>
		<category><![CDATA[Central Drugs Standards Organisation]]></category>
		<category><![CDATA[Diagnose]]></category>
		<category><![CDATA[ECG]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Food and Drugs Administration]]></category>
		<category><![CDATA[Foreign Direct Investment Policy]]></category>
		<category><![CDATA[Gadgets]]></category>
		<category><![CDATA[General wellness apps]]></category>
		<category><![CDATA[Hardware device]]></category>
		<category><![CDATA[Health-tech]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[Human Intelligence]]></category>
		<category><![CDATA[IMDRF]]></category>
		<category><![CDATA[International Medical Devices Regulation Forum]]></category>
		<category><![CDATA[Internet of Things]]></category>
		<category><![CDATA[Invasive device]]></category>
		<category><![CDATA[IoT]]></category>
		<category><![CDATA[Manas Ingle]]></category>
		<category><![CDATA[Med-tech]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Medical device directive]]></category>
		<category><![CDATA[Medical devices rules 2017]]></category>
		<category><![CDATA[Novojuris Legal]]></category>
		<category><![CDATA[SaMD]]></category>
		<category><![CDATA[Sensor]]></category>
		<category><![CDATA[Software]]></category>
		<category><![CDATA[Software as medical device]]></category>
		<category><![CDATA[tectonic]]></category>
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		<category><![CDATA[Wearable device]]></category>
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					<description><![CDATA[<p>The tectonic shifts in technology are transforming human life in ways unfathomable just a few years ago. Health-tech and med-tech are touching our lives continuously through a number of ways – from simple wearable devices to complex invasive devices</p>
<p>The post <a href="https://innohealthmagazine.com/2018/issues/software-as-medical-device/">Software as Medical Device</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
]]></description>
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	<p style="text-align: justify !important;">The tectonic shifts in technology are transforming human life in ways unfathomable just a few years ago. Health-tech and med-tech are touching our lives continuously through a number of ways &#8211; from simple wearable devices to complex invasive devices; simple AI software which can predict and sense to complex AI software which can diagnose; sensors and other hardware devices including the mobile phone with ever-increasing computing power.</p>
<p style="text-align: justify !important;">Some of these have made human lives so dependable on these devices, gadgets, software. In some cases, these are dumping human intelligence. We witnessed software wherein by looking at a camera on the mobile phone. The software can predict the heart rate and many other vitals. What if human intelligence gave way in believing the reading as true? The software or the camera is not a medical device. Hence outside the purview of regulations usually applicable to medical devices. Can we ignore the risks? If so, should software be treated as a medical device?</p>
<h3>Software as Medical Device (SaMD)</h3>
<p style="text-align: justify !important;">A broadly accepted definition of a SaMD is the one issued by the <a href="http://www.imdrf.org/">International Medical Devices Regulation Forum (“IMDRF”)</a>; Currently, Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore and the USA are member countries to this Forum. The FDA has adopted this definition in the US. The Medical Device Directive adopted by the EU in 2010, and in major countries such as Australia, Canada and Japan.</p>
<p style="text-align: justify !important;">The term “Software as a Medical Device” is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. It includes an in vitro diagnostic medical device. SaMD must be capable of running on a computer platform that is not of a medical purpose. And should not need a hardware medical device to achieve its purpose. It can be interfaced or used in a combination with other devices. But cannot be used to drive a hardware device.</p>
<p style="text-align: justify !important;">The definition, Mobile Application Meeting, also consider as SaMDs. The medical purpose‟ that it must intend to serve can be diagnostic, preventive, investigative, life-sustaining, for treatment of disease or injury, disinfection, control of conception or purely informative. In some jurisdictions, aids for persons with disabilities, devices for assisted reproduction and devices incorporating animal and/or human tissues are also recognized.</p>
<p style="text-align: justify !important;">A SaMD can also be a means to suggest mitigation of a disease or provide aid to diagnosis. There are further guidelines on the definition of changes to SaMDs- they can be adaptive, corrective or preventive in nature. The manufacturer of SaMD would be a natural or legal person who has the intention for the software to be used under his/its name. It would not include a distributor or the manufacturer of an accessory. The final legal responsibility lies with the manufacturer unless it specifically imposes on another party by the country’s regulatory authority.</p>
<h3>Putting them to use</h3>
<p style="text-align: justify !important;">SaMDs are now available in abundance in the Indian market. Both foreign manufacturers, as well as Indian manufacturers, are introducing so many forms of SaMDs. This includes the use of artificial intelligence, IoT, general software etc. Interesting, many SaMDs are enjoying high adoption rates not only for early users but continued users. The glaring point is that there is no legislative framework or guidance policy which works as a guiding principle for the SaMD manufacturers or at least as a self-regulating piece of legislation, in India.</p>
<p style="text-align: justify !important;">The Medical Devices Rules, 2017 which has come into effect from January 1, 2018. Now defined medical devices and has made a clear distinction between drugs and medical devices. But still, this definition does not include SaMDs or software as a medical device. Interestingly, the draft Medical Devices Rules, 2016 on basis of which the Medical Devices Rules, 2017 have been formalized included software in the definition of medical device. AI, IoT, general software, wearable, and wellness and customized medical devices are flooding with the market. Software as a medical device as a whole should consider with equal importance in the sector. Curiously, the definition of medical devices under Foreign Direct Investment policy includes software.</p>
<h3>Regulations</h3>
<p style="text-align: justify !important;">The IMDRF has worked extensively in setting guiding principles for governing SaMD and has put in place a regulatory structure for how the SaMDs shall be governed, regulated, clinically evaluated and how the data shall be evaluated and then used by the SaMD. While India has not yet included any software or apps in its regulatory purview. Countries like U.S.A, Singapore, Australia, EU and Japan has issued guidance documents to make the app developers aware of what might subject to regulation.</p>
<p style="text-align: justify !important;">The common theme that determines the classification is the level of risk that these apps pose to the consumers. For example, let’s take an app which allows a user to take ECG test by putting their fingers on an external device which is connected wirelessly to the smartphone. It checks the electrical activity of the heart. Such apps may be considered as risky and be subject to regulation since the belief is that any incorrect analysis may hamper a user’s treatment. However, the Government authorities need to strike a balance while assessing these risks so that not all apps need to be certified under the law so that innovation is not hampered.</p>
<p style="text-align: justify !important;">It is indeed a very fine balance. General wellness apps or products such as apps tracking and assisting in maintaining healthy body weight. Products are generally kept out of the purview of law versus apps which tracks and assists in say monitoring blood sugar or other vitals or treats specific health issues or provides guidance for treatment of specific illnesses. The whole purpose to bring these apps under regulation is that there is a certain amount of rigour before the apps are released to the market. And there is onus and responsibility on these makers. It should enable the app developers to be mindful of how is the product advertises, claims as well.</p>
<p style="text-align: justify !important;">To protect consumers, certain jurisdictions, like Singapore, have mandated the manufacturers/ app developers to put a clarification statement on their product or on their apps. This statement should clearly state that this app or product is not intended to be used in a diagnosis, monitoring, management or treatment of any disease. Keeping all the innovation in health-tech space, India should provide guidance on SaMDs. The regulatory framework in India for medical devices is by the <a href="http://www.cdsco.nic.in/">Central Drugs Standards Organization</a> widely known as <a href="http://www.cdsco.nic.in/">CDSCO</a>.</p>
<p style="text-align: justify !important;">The new Medical Devices Rules, 2017 are comprehensive and now extensively covers almost 351 medical devices and about 247 in-vitro medical devices. It still does not cover SaMDs. Given the increased use of mobile technology and awareness, guidelines on SaMDs could contribute to improving the affordability and availability of healthcare, including rural India, which has a huge user base. Gradual rigour in legislation will allow India to meet increased need, according to when resources for monitoring and enforcement become more available. India already follows the IMDRF regulations with respect to clinical trials. And the clinical evaluation of medical devices, with respect to documents, licensing and safety standards.</p>
<p style="text-align: justify !important;">It is important for the legislation to allow the industry to grow and achieve its potential. Especially in a country like India where there is a need for the better point of care medical solutions. But at the same time provide unambiguous guidance. A good starting point would be a self-regulating mechanism with a set of standards, methods and procedures, clinical evaluation process. Such guidance would help improve innovation as well and guide the nascent Indian SaMD industry.</p>
<p style="text-align: justify !important;"><em><strong>(Author is a qualified lawyer who has a keen interest in how tectonic shifts in technology is impacting healthcare delivery. The intersection of law, innovation, interaction with man and machine excites him. Manas works with NovoJuris Legal deeply in AI, IOT, health-tech, med-tech, devices and more in the healthcare segment)</strong></em></p>
<h3><a href="https://innohealthmagazine.comtime-to-take-intelligent-decisions/">A new paradigm for use of machine intelligence in healthcare</a></h3>
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<p>The post <a href="https://innohealthmagazine.com/2018/issues/software-as-medical-device/">Software as Medical Device</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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		<title>Upcoming Cyber Security Threats in Health Sector</title>
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		<pubDate>Thu, 16 Nov 2017 06:25:35 +0000</pubDate>
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					<description><![CDATA[<p>By Sachin Gaur</p>
<p>The post <a href="https://innohealthmagazine.com/2017/issues/cyber-security-threats/">Upcoming Cyber Security Threats in Health Sector</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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	<p style="text-align: justify !important;">Sachin Gaur is director operations at <a href="http://www.innovatiocuris.com">InnovatioCuris</a>. He is interested in topics of mHealth and Cyber Security.</p>
<p style="text-align: justify !important;"><strong>Abstract:</strong> We are seeing phenomenal technology shifts and human life is greatly impacted by them. Health sector is not untouched as the health systems now have deep IT integration and care givers increasingly rely on the information shown by digital systems. Hence, any compromise to the integrity of such systems would lead to wrong diagnosis or treatment. This paper investigates some of the early signals about the kind of threats out there relevant to the health systems.</p>
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	<p><span style="color: #0071b2;"><strong>Introduction</strong></span></p>
<p style="text-align: justify !important;">The famous Silicon Valley investor Marc Andreessen says, “software is eating the world”. By, which he means that increasingly we are bringing software into systems to increase efficiency, lower down the cost or time involved in the process. Interestingly, humans also do software writing and humans are prone to make mistakes. It is estimated by various experts that 1000 lines of code (KLoC) has approximately 15-50 bugs present. Bugs here mean mistakes made by the software programmer while writing the software code. Bugs often result in some kind of malfunction or wrong output. Some of these bugs can lead to exploit by a third party making the larger system vulnerable or as we call hackable. As long as humans will write software, bugs will be there.</p>
<p style="text-align: justify !important;">In a typical software company as bugs are discovered, new code is written to fix these bugs. The new code might further result into new bugs hence the cycle continues. At the consumer end, we keep receiving software updates over the air, as we use our phone / laptops or other devices, which are many times an attempt of the software company to overcome the past mistakes.</p>
<p style="text-align: justify !important;">A lone computer hacker or an organized crime group looks at these software updates (sometimes called patches) very curiously as for them this could be a chance of hitting the jackpot! They reverse engineer it and try to understand the bug, that the patch is trying to cover. Very often systems are not updated with latest updates. Leading to most system having a known vulnerability, which the hacker can take advantage after understanding it well. Hackers further can create a simple script (programming code snippet) to some sophisticated software, which can then take advantage of the vulnerable system. We often call such a program as malware, as it is built with bad intention.</p>
<p style="text-align: justify !important;">Today, as we talk it has become from a hobby crime to organized crime! Software companies regularly receive communication from bounty hunters about exposing their critical software bugs and in exchange not to do so, hackers want to charge them bounty money. Some software companies have gone further and engaged these bounty hunters to reduce security risks in their software.</p>
<p style="text-align: justify !important;">In some cases the hacker is not interested in the bounty money (hence they do not inform the software maker) but rather interested in exploiting the bug. Sometimes, the bug is not known to the software maker or anyone else in the world and can be converted into a lethal attack. Such attacks are known as a zero day attack! As prior knowledge of such a vulnerability does not exist. Hence, most software security solutions, like anti virus software do not work on them. Further selling the knowledge of exploit as lethal software is now called as a cyber weapon. Nation states are now engaged in buying or building such software to infect systems of enemy states. Hence, we have come very far in the business of software bugs, where the enemy could be a lone developer, an organized crime group or a Nation state.</p>
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	<p><span style="color: #0071b2;"><strong>How is software eating the health sector and the threats linked to it?</strong></span></p>
<p style="text-align: justify !important;">In the above section we discussed in general, how the exploitation of software is increasingly becoming a serious business. While, we have seen many examples in last 30 years from a hobby software programmer to Nation states taking advantage of the software driven vulnerabilities. We would like to share some examples closer to the health sector.</p>
<p><strong>1. Malware affecting data systems</strong></p>
<p style="text-align: justify !important;">Hospital information systems and similar information systems as part of the healthcare delivery have become very commonplace and one of the core component of the system. As pointed out in the introductory section, organized crime groups are now looking to exploit software bugs for commercial purposes. One of the ingenious way that they have developed is a malware known as ransomware . Ransomware is a malicious computer program which when executed on a system encrypts the data with very strong encryption making it unusable for hospitals or any other care provider to access patient records or other vital information. It then demands a ransom inform of bitcoins (a crypto currency) in order for the victim to have the key to decrypt the vital information. In recent incidents of ransomware infection, some hospitals in USA have even demanded millions of dollars as ransom and some have even paid.</p>
<p style="text-align: justify !important;">The mitigation strategy for countering ransomware for any organization would be a strong backup of data. Also, creating awareness among the employees on sources of malware and reducing the chances of accidental infection of the workplace systems.</p>
<p style="text-align: justify !important;">The long-term solution of tackling such organized crime is a better international legal framework, which allows international prosecution and cooperation among law enforcement agencies.</p>
<p><strong>2. Denial of service attacks on ehealth services</strong></p>
<p style="text-align: justify !important;">In 2007 there was a distributed denial of service attack that took place in Estonia. A statue of the Russian soldier was removed from the Tallinn Square, capital of the country. Which sparked a response from sympathizers from Russia and it brought down the Estonian economy for three days. Estonia being one of the most advance countries when it comes to take up of e governance services, ehealth being one of them. The entire attack costed less than 50,000 US dollars. That was the first Denial of service attack the world saw at the level of a nation state.</p>
<p style="text-align: justify !important;">The basic premise behind such an attack is that you have a service (e-service) to be provided to citizens over Internet like their own health records for example. The provider would have some finite amount of bandwidth and computing power at the backend of the service correlating to the average load on the service. In a distributed denial of service attack, the attacker uses compromised computing devices (commonly known as a bot) to access the Internet service. The botnet, which is a collection of such bots could be having thousands or millions of such devices that simultaneously access the service. The service provider is not able to distinguish the normal traffic from the bot traffic and often the server crashes under the heavy load. For a normal user trying to access the service, the service is unavailable because of the finite resources of the server being exhausted by the bot traffic. Hence, it is called a denial of service attack.</p>
<p style="text-align: justify !important;">Hence, when a city, state or a nation is considering providing an eservice to citizens it could witness such attacks. One strategy to mitigate such attacks is to have tracking of the server traffic for any anomalies and having redundancy available in the system. This is achieved many times by putting the service on a cloud, which can tolerate such traffic fluctuations.</p>
<p><strong>3. Data leak and breaches</strong></p>
<p style="text-align: justify !important;">Many health systems or systems require some kind of authentication mechanism to log in to the system in order to access the service. Many a times these are text password based systems behind which, important patient profile or health records information is stored. The largest of the companies like that of Google, Microsoft etc have seen attacks where the attacker is able to leak the passwords of millions of their customers. Such scenarios result in massive breach of data privacy and compromise for customers.</p>
<p style="text-align: justify !important;">Good security practices, proper encryption of data and regular updates of the system are some of the key considerations for avoiding such instances. Nowadays, two-factor authentication has become a standard practice for making the authentication systems more robust. However, still some user awareness is needed to opt for better security practices whenever possible.</p>
<p><strong>4. Hacking medical devices and health system</strong></p>
<p style="text-align: justify !important;">If we look at the building blocks of the health systems, where information technology is deeply integrated. We have already covered the health information systems, eservices and patient interface of authentication into the services. However, increasingly we hear about Internet of Things (IoT) devices in the health sector domain. Which means the integration of Internet services into traditional medical devices or new age devices, which have also connectivity. For example, a thermometer which can send the temperature data to your phone or a stethoscope which can record the patient breathing sound and upload in a server for finding patterns of lung diseases. These are powerful use cases and provide great opportunity to clinicians and care providers, where they have greater computation power available to them and they are able to do more with less. However, these IoT devices are prone to the same kind of attacks as any other communication device or a software program. They can be compromised to show wrong values and totally messing up the diagnosis. There are already such instances. One such instance not related to health sector but important is of the Stuxnet. Stuxnet was designed for the SCADA systems of Iranian nuclear program by USA and Israel in order to delay their nuclear program.</p>
<p><strong>5. Stealing identity information</strong></p>
<p style="text-align: justify !important;">As mentioned in the point 3, about data leaks and breaches at the system level. One problem, which can arise from such an attack, is a further more damaging attack that is stealing of identity information. In India, mobile phones to receive an sms message containing one time password is increasingly becoming a standard practise because of being cost effective, simple and secure. Any such application, which you may install on your phone, can also get access to the sms and other features of your phone. Meaning the incoming sms or calls can also be stolen by this application to complete the transaction on your behalf. As increasingly we have to prove ourselves using biometrics or passwords to online systems. It is possible for the attackers to steal these credentials and access our records without our knowledge. Hence, any third party applications that we install on our devices (especially phone) , we need to be very careful about the type of access control they have on our devices.</p>
<p><strong>6. Implantable medical devices with communication interfaces:</strong></p>
<p style="text-align: justify !important;">In 2007, the former US Vice President, Dick Cheney’s implanted pacemaker’s wireless communication was disabled fearing a terrorist attack. This sounds like science fiction to many but incident has already happened ten years back! Many of the medical devices are built with a communication interface and it is quite normal for a typical pacemaker or other such devices to have a Bluetooth or a similar communication technology based interface for remote diagnosis and other purposes. While, the communication ability of such a device was planned for looking at the state of the pacemaker it was not designed with keeping security in mind. Hence, it is possible that someone can connect to a critical device like pacemaker and shuts it down remotely.</p>
<p style="text-align: justify !important;">One more reason that such exploits are possible increasingly as computing is becoming cheaper. What seems strong security today might not be strong tomorrow. However, an implantable device might stay in the patient’s body for tens of years. Hence, we need to have a long-term view on the communication interfaces and their capabilities on such devices. We need to make considerations on control and information capabilities of these interfaces. Misuse of control capabilities can lead to even death and misuse of information capabilities can lead to breach of patient privacy.</p>
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	<p><span style="color: #0071b2;"><strong>Way forward: why Internet is the new breeding ground for crime?</strong></span></p>
<p style="text-align: justify !important;">The law of the land governs the Internet in every country and hence the legal regime globally is very fragmented. However, a user of Internet does not see any borders or walls and so is the criminal. They build their criminal businesses where they do not fear strict government action and often for paltry sums the user or the national law enforcement agencies do not pursue the criminal cases cross border.</p>
<p style="text-align: justify !important;">On top of it newer crypto currencies like Bitcoins, makes it easy to make such transaction in an anonymous manner. Dark net marketplaces provide a breeding ground for criminals to conduct illegal transactions of billions of dollars without getting caught. So, the three important components, weak legal enforcement, anonymous currency and secret marketplaces are enabling the cyber crime to flourish. If we want to slow it down, we will need greater international collaboration among lawmakers and user awareness at all levels.</p>
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	<p><span style="color: #0071b2;"><strong>Reference:</strong></span><br />
<strong>(i)</strong> <a href="https://www.wsj.com/articles/SB10001424053111903480904576512250915629460">https://www.wsj.com/articles/SB10001424053111903480904576512250915629460</a><br />
<strong>(ii)</strong> <a href="http://labs.sogeti.com/how-many-defects-are-too-many/">http://labs.sogeti.com/how-many-defects-are-too-many/</a><br />
<strong>(iii)</strong> <a href="https://www.ted.com/talks/mikko_hypponen_fighting_viruses_defending_the_net/transcript?language=en">https://www.ted.com/talks/mikko_hypponen_fighting_viruses_defending_the_net/transcript?language=en</a><br />
<strong>(iv)</strong> <a href="https://hackerone.com">https://hackerone.com</a><br />
<strong>(v)</strong> <a href="https://en.wikipedia.org/wiki/Zero-day_(computing)">https://en.wikipedia.org/wiki/Zero-day_(computing)</a><br />
<strong>(vi)</strong> <a href="https://en.wikipedia.org/wiki/Cyberweapon">https://en.wikipedia.org/wiki/Cyberweapon</a><br />
<strong>(vii)</strong> <a href="https://en.wikipedia.org/wiki/Ransomware">https://en.wikipedia.org/wiki/Ransomware</a><br />
<strong>(viii)</strong> <a href="https://en.wikipedia.org/wiki/Bitcoin">https://en.wikipedia.org/wiki/Bitcoin</a><br />
<strong>(ix)</strong> <a href="http://www.csoonline.com/article/3033160/security/ransomware-takes-hollywood-hospital-offline-36m-demanded-by-attackers.html">http://www.csoonline.com/article/3033160/security/ransomware-takes-hollywood-hospital-offline-36m-demanded-by-attackers.html</a><br />
<strong>(x)</strong> <a href="https://www.theguardian.com/technology/2016/feb/17/los-angeles-hospital-hacked-ransom-bitcoin-hollywood-presbyterian-medical-center">https://www.theguardian.com/technology/2016/feb/17/los-angeles-hospital-hacked-ransom-bitcoin-hollywood-presbyterian-medical-center</a><br />
<strong>(xi)</strong> <a href="http://innovatiocuris.com/looming-danger-of-ransomware/">http://innovatiocuris.com/looming-danger-of-ransomware/</a><br />
<strong>(xii)</strong> <a href="http://www.bbc.com/news/technology-24608435">http://www.bbc.com/news/technology-24608435</a></p>
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<p>The post <a href="https://innohealthmagazine.com/2017/issues/cyber-security-threats/">Upcoming Cyber Security Threats in Health Sector</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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