Tag Archives: cyber security

Cyber-Security: The Vulnerability of Medical Institutions to Cyber-Attacks

McAfee 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 needs urgent consideration. Just as financial data is loved by the cybercriminals, so is health data becoming a gold-mine with the cyber offenders. Specially so when the hospitals are run on legacy systems or no dedicated framework or surveillance on its 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;[i]

A number of cyber-attacks on medical institutions are initiated to extract the electronic health records (EHRs). These EHRs may contain personal health information of the patients, their 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 only 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) 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, computer 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 NHS mail (the NHS email system).

In India, as reported by multiple news agencies, last year in the month of June 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 cyber-attacks arises due to many reasons, outdated digital infrastructure or medical personnel not being aware or not trained about cyber-attacks. 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 emails, or (e) phishing etc. It is time that our healthcare providers upgrade their technologies, networks, understanding on this subject.

Regulatory bodies across the world have suggested / adopted guidelines and standards to ensure necessary cybersecurity processes and controls which helps medical institutions to mitigate cyber risks and vulnerabilities. For the purpose of this article we will be primarily focusing on various safeguards and standards put in place by European Union and India to deal with such cyber-attacks.

Position in Europe

As a part of the EU cybersecurity strategy, the European Commission adopted the EU Network and Information Security Directive (“NIS Directive”) on 6 July 2016 and the same 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 (i) national capabilities, (ii) cross-border collaborations and (iii) national supervision of the critical sectors including health.

  • 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”).
  • Cross Border collaborations: The NIS Directive encourages collaborations between EU member states like the EU CSIRT network, the NIS cooperation group, ENISA etc.
  • 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 (i) identification criteria of cyber-attacks, (ii) incident notification, (iii) security requirements for Digital Signal Processors (DSPs), (iii)  mapping of operators of essential services (OES) security requirements for specific sectors including health and (iv) 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 ensures protection of consumers, facilitates cross-border trade, ensures interoperability of goods/products, encourages innovation and technological development, and includes environmental protection and enables businesses to grow.[ii]

The General Data Protection Regulations (“GDPR”)[iii] specifically defines ‘data concerning health’, ‘genetic data’ and ‘bio metric 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.

Position in India

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 cyber security 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 cyber security incidents occurring in India and analysing information related to cyber-crimes, 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[iv].

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 cyber security incidents, (c) laying down emergency measures for handling cyber security incidents, (d) coordinating cyber incident response activities, (e) issuing guidelines, advisories, vulnerability notes and whitepapers relating to information security practices, procedures, prevention, response and reporting of cyber incidents, and (f) performing any other functions relating to cyber security as may be prescribed[v].

CERT-India in the last five years or so has focused on making various institutions who are highly dependent on cyber/digital networks ‘cyber resilient’. Being cyber resilient allows these institutions which is nothing but a process of effectively anticipating the various threats and the mechanism of dealing with the cyber-attacks. Anticipate, withstand, contain and recover are the 4 main contours of being cyber resilient[vi]:

  • Anticipate: Maintain a state of informed preparedness in order 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 cyber attacks
  • 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, so as to minimize adverse impacts from actual or predicted adversary attacks

To strengthen the framework and to ensure that reasonable security practices and procedures are followed, the Department of Information Technology introduced certain Rules. The Rules requires each and every body corporate including medical institutions who are collecting such 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 cyber-attacks reported worldwide are caused due to reasons which sometimes are trivial and perhaps ignored more often, such as out-dated Windows operating system patch, lack of proper anti-virus or reasons such as phishing, lack of awareness among the people about cyber security etc.

EU, through GDPR has made data security an integral part of law and India is taking strong steps have a robust data protection and data security law. Various regulations, programmes, codes, standards etc. discussed in this article are some 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 has to take steps to safeguard its networks and systems from such threats.

References:

[i] Article 4.1 General Data Protection Regulations (GDPR).

[ii]CENELEC, Marketing Standards for Europe, available at: https://www.cencenelec.eu/aboutus/Pages/default.aspx

[iii] GDPR (2016/679) is a regulation in EU law on data protection and privacy for all individuals within the European Union and the European Economic Area

[iv] Section 70B (4) of the Information Technology Act, 2000

[v] Supra footnote 1

[vi] CERT- In, Cyber Crisis Management Plan for Countering Cyber Attacks and Cyber Terrorism

 

This article was first published at Innohealth Magazine, Volume IV Issue II

Advertisements

Basic Cyber Security Framework for Primary (Urban) Cooperative Banks (UCBs)

The Reserve Bank of India (RBI) on October 19, 2018 issued a set of guidelines for Basic Cyber Security Framework for Primary (Urban) Cooperative Banks (UCBs). Such a framework was issued by the RBI as a measure to enhance security of the UCBs in light of the increasing number and impact of cyber security attacks on the financial sector including banks. [1]

  1. Board Approved Cyber Security Policy
  • All UCBs need to immediately put in place a Cyber Security policy, duly approved by their Board/Administrator, giving a framework and the strategy containing a suitable approach to check cyber threats depending on the level of complexity of business and acceptable levels of risk.
  • On completion of the process, confirmation of same within 3 months must be sent to the Department of Co-operative Bank Supervision.
  • The Cyber Security Policy should inter alia encapsulate the following concerns:
  • Preventing access of unauthorised software.
  • Network Management and Security.
  • Secure Configuration.
  • Anti-virus and Patch Management.
  • Secure mail and messaging systems.
  • The IT framework/framework must be reviewed periodically by the Board or its IT subcommittee in order to identify vulnerable areas and put in place a suitable cyber security system to address the issues after assessment.
  1. Cyber Crisis Management Plan
  • The Cyber Crisis Management plan, prepared by CERT-In (Computer Emergency Response Team – India maybe referred to by the UCBs for guidance.
  • UCBs should promptly detect any cyber intrusions (unauthorised entries) so as to respond/recover/contain impact of cyber-attacks, especially those offering services such as internet and mobile banking, RTGS/NEFT/SWIFT, credit and debit cards etc.
  1. Organizational Arrangements
  • UCBs should review the organisational arrangements so that the security concerns are brought to the notice of suitable/concerned officials to enable quick action.
  • UCBs should actively promote among their customers, vendors, service providers and other concerned parties an understanding of its cyber security objectives.
  • UCBs, as owners of customer sensitive data, should take appropriate steps in preserving the Confidentiality, Integrity and Availability of the same, irrespective of whether the data is stored/in transit within themselves or with the third party vendors; the confidentiality of such custodial information should not be compromised in any situation.
  • UCBs to put in place suitable systems and processes across the data/information lifecycle. UCBs may educate and create awareness among customers with regard to cyber security risks.
  1. Supervisory reporting framework
  • UCBs should report immediately all unusual cyber security incidents (whether they were successful or mere attempts) to Department of Co-operative Bank Supervision giving full details of the incident.
  • UCBs are advised to implement basic Cyber Security Controls and report the same to respective Regional Offices of Department of Co-operative Bank Supervision on or before March 31, 2019.

Source: http://www.rbi.org.in/scripts/NotificationUser.aspx?Id=11397&Mode=0

https://rbidocs.rbi.org.in/rdocs/content/pdfs/63NT19102018_A1.pdf

[1] http://www.rbi.org.in/scripts/NotificationUser.aspx?Id=11397&Mode=0.

DATA SECURITY AND PRIVACY IN MEDICAL DEVICES

Medical devices have seen quantum leaps in terms of functionality, intelligence, and usefulness in the last decade. Improved design, better and cheaper production materials, and more sophisticated software, and have all contributed to this improvement. However, perhaps the biggest recent development that has greatly enhanced the ability and uses of medical devices, is the use of technology to connect medical devices (including those implanted in humans) to the internet, to hospital systems, and to other devices. This makes it possible to make these devices smarter, to control them remotely if required, to monitor their activity and functioning, and to pause or alter their operation without having to remove them from the human body.

However, like all devices that come with internet connectivity, these connected medical devices come with one major potential harm – the vulnerability to hacking, malware, and/or viruses. Potentially, this could create havoc for health care providers and patients, as third-parties may be able to break into and dictate the functioning of medical devices such as drips or other implanted devices. This problem is not new either. Since 2012, the Food and Drug Administration of the USA (the “FDA”) has been increasing security infrastructure standards for all connected medical devices, and has been constantly warning manufacturers of potential threats.

Sure enough, a short while ago, the first major medical device manufacturer in the USA suffered from the threat of security breaches. On August, 30, 2017, the FDA announced the recall of approximately 465,000 pacemakers manufactured by Abbot (previously St. Jude Medical), due to the fear of security vulnerabilities being exploited by hackers. As per the FDA, if the vulnerabilities were left unremedied, hackers could reprogram the pacemakers to alter the heart rate of the patient and/or to drain the batteries quickly. Both scenarios could have potentially catastrophic effects.

Fortunately for Abbot, the vulnerabilities could be fixed via a firmware update that could be installed by health care providers in just 3 minutes. The pacemakers did not need to be removed from the patients’ bodies, as the update could be installed wirelessly. Further, Abbot was able to report that there had been no incidents of a security breach/hack before the firmware update was rolled out. Yet, this should not detract from the seriousness of the situation and the extent of the harm that could have been suffered by both the manufacturer and the patients. In light of this, we find it pertinent to take a deeper look at the different minds of medical devices available today, and the potential harm that can be caused through them if the current security infrastructure is not in place.

Medical Devices and Their Potential Harms

Medical devices, apart from being controlled remotely, are also great repositories of data. In order to be able to automatically adjust their own functionality, alert users/controllers at times of low battery, and to be able to provide efficient statistics as to the health of a patient, they have to constantly collect, monitor and analyse data from the patient’s body. This means that they contain sensitive personal information regarding patients’ medical conditions, bringing in the important aspect of data privacy.

Medical devices have been used for a variety of purposes – from diagnosis of multiple diseases, to studying patient’s conditions during treatment of diseases, and to ensuring patient adherence to a prescribed treatment plan. Perhaps, given the wide range of uses for connected medical devices, it will be easier to understand the problems that they may face, by taking a few examples:

  1. OpenAPS – Closed loop insulin delivery – This software, which can be used along with standard medical devices, allows patients to track data from their CGM (continuous glucose monitor), and use it to control/trigger their insulin pump whenever glucose levels demand the same. The patients PII is not owned by any third party here, but if hacked, this system could not only give hackers access to this information, but could also allow hackers to alter the trigger mechanism/program that controls when insulin is released to
  2. Activity trackers during cancer treatment – These devices are used to gather lifestyle data regarding patients, during their treatment from various forms of cancer. These are wearable devices (like many other activity trackers/smart watches), but they track the patient’s energy levels, fatigue, and appetite automatically. The data generated via these devices is usually accessible and analysed by doctors and other health care providers. In a disease where the treatment is actively changed depending on the patient’s reaction to the ongoing medication/therapy, such a device is extremely important. Additionally, it aids doctors to keep track of a patient’s lifestyle, to ensure that patients are taking care of themselves appropriately. Thus, this device places data privacy and security restrictions on doctors etc., with respect to the PII that they hold. Additionally, there is a responsibility on the manufacturers of such devices to ensure that the security infrastructure of the device is strong enough to protect it against hacks/malware. If hacked, not only will the critical data regarding a patient’s current condition be available to the hacker, but they can also alter the functioning of the device to change the readings. This could potentially prevent a cancer patient from receiving the correct follow-on treatment, which is critical to their health.
  • Connected inhalers – Devices like Propeller’s Breezhaler connect wirelessly to a digital platform available on the patient’s mobile phones and with the doctors as well. This helps in tracking the usage of the inhaler, sending reminders to the patient in case of sporadic usage, and ensuring patient adherence to a treatment plan. If such systems are hacked, patients and doctors could stop receiving accurate data regarding inhaler usage, potentially leading to non-adherence to treatment plans and a worsening of existing breathing problems.
  1. Parkinson’s – Pfizer and IBM have collaborated on Project Blue Sky, a planned clinical trial involving the use of a system of sensors, mobile devices, and machine learning to provide round-the-clock monitoring of the symptoms, development and progression of Parkinson’s in patients. Though more research oriented, such a system could potentially be extremely important in discovering a cure for Parkinson’s.

The above are only a few examples of connected medical devices available today. Yet some common themes run through all of them – (a) they all record and store sensitive personal information regarding patients in order to function; (b) they are all accessible remotely; and (c) this makes them vulnerable to hacking/malware etc. Considering the nature of the information stored on the devices, it becomes even more important for the manufacturers to ensure data security of the devices, and for the doctors/other entities storing and analysing the data to ensure its privacy and non-disclosure. No data security infrastructure is fool proof or completely protected from hackers. However, increased standards and more robust protection techniques could help in ensuring that these devices remain protected in the near future.

Author: Madhav Rangrass is an Associate with NovoJuris Legal.