GDPR Archives - InnoHEALTH magazine

WHO's First Guideline to Digital Health Interventions

InnoHEALTH Magazine — Wed, 31 Jul 2019 09:46:27 +0000

On 17th April 2019, WHO released a ‘new recommendations on 10 ways that countries can use digital health technology, accessible via mobile phones, tablets and computers, to improve people’s health and essential services’. Harnessing the power of digital technologies is essential for achieving universal health coverage, says WHO Director-General Dr. Tedros Adhanom Ghebreyesus. Ultimately, digital technologies are not ends in themselves; they are vital tools to promote health, keep the world safe, and serve the vulnerable.

Over the past two years, WHO systematically reviewed the evidence on digital technologies and consulted with experts from around the world. This guideline is a roadmap to research for global health so as to strengthen countries health systems. It is to be effective, sustainable and responsible.

“The use of digital technologies offers new opportunities to improve people’s health,” says Dr. Soumya Swaminathan, Chief Scientist at WHO. “But the evidence also highlights challenges in the impact of some interventions.” She adds: “If digital technologies are to be sustained and integrated into health systems, they must be able to demonstrate long-term improvements over the traditional ways of delivering health services.”

Dr. Oommen John, Senior Research Fellow, George Institute says, India is a hub for digital health innovations, however very few of these innovations have achieved the scale for impact within the health systems. It is important therefore to pause, reflect and use the WHO digital health guidelines as framework of the innovation ecosystem in India and help guide energy and enthusiasm of the start-ups to develop, evaluate and implement digital health innovations that can help achieve the universal health coverage.

The guideline encourages policy- makers and implementers to review and adapt to these conditions if they want digital tools to drive tangible changes and provides guidance on taking privacy considerations on access to patient data.

“Digital health is not a silver bullet,” says Bernardo Mariano, WHO’s Chief Information Officer. “WHO is working to make sure it is used as effectively as possible. This means ensuring that it adds value to the health workers and individuals using these technologies, takes into account the infrastructural limitations, and that there is proper coordination.”

Mr. Mariano also said: “Digital Health is the future of healthcare. As we take the big leap into digital health, we must ensure that it is people centric, delivers positive health outcomes, does no harm to people and it actually improves the healthcare system as a whole.”

It is a ‘Living Guideline’ i.e. it will be updated regularly as new evidence becomes available. This Guideline has been completed under the newly formed section at the WHO: Norms and Standards section in the WHO. This Guideline has been regarding: Reproductive Health & Research and has four outcomes:

Health systems to have health data for accountability
Helping health workers to work efficiently
For tracking medical commodities to provide services
Making sure health coverage for all

Since it is a developing guideline and is meant to be stringent based on evidence alone; it is a path finder for a whole gamut of health issues. For each recommendation, a summary of the evidence on the positive and the negative effects has been provided.

Dr. Garrett Mehl, Scientist, Digital Innovation and Research, WHO says: “Digital interventions depend heavily on the context and ensuring appropriate design. This includes structural issues in the settings where they are being used, available infrastructure, health needs they are trying to address, and the ease of use of the technology itself.” Importantly, it must be noted that: “Digital health interventions are not sufficient on their own.”

The guideline recommendations about telemedicine, which allows people living in the remote locations to obtain health services by using mobile phones, web portals, or other digital tools. WHO points out that this is a valuable complement to face-to-face- interactions, but it cannot replace them entirely. It is also important that consultations are conducted by qualified health workers and that the privacy of individuals’ health information is maintained. The guideline emphasizes the importance of reaching vulnerable populations, and ensuring that digital health does not endanger them in any way.

Trusted Exchange Framework and Common Agreement (TEFCA)

On 19th April 2019, US Department of Health and Human Resources (HHS’) announced the next steps in advancing operability of health information by opening up the second draft of the Trusted Exchange Framework and Common Agreement (TEFCA) for public comment. TEFCA, would support the full, network-to-network exchange of health information nationally. Specifically, the documents being released for comments are: (1) a second draft of the Trusted Exchange Framework (TEF), (2) a second draft of the Minimum Required Terms and Conditions (MRTCs) for trusted exchange, and (3) a first draft of a Qualified Health Information Network (QHIN) Technical Framework. These documents will form the basis of a single Common Agreement that QHIN’s and their participants may adopt. This Common Agreement will create baseline technical and legal requirements for sharing electronic health information on a nationwide scale, across disparate networks.

“The seamless, interoperable exchange of health information is the key piece of building a health system that empowers patients and providers and delivers better care at a lower cost,” said HHS Secretary Alex Azar. “The 21st Century Cures Act took an important step towards this goal by promoting a national framework and common agreement for the trusted exchange of health information. We appreciate the comments and input from stakeholders so far and look forward to continued engagement.”

In developing a TEFCA that meets industry’s needs, HHS’ Office of the National Coordinator (ONC) for Health Information Technology focused on three high-level goals:

Provide a single “on-ramp” to nationwide connectivity
Ensure electronic information securely follows you when and where it is needed; and
Support nationwide scalability for network connectivity

ONC will maintain the TEF, while a non-profit, industry-based organization, known as the Recognized Coordinating Entity (RCE), will be awarded funds to develop, update, implement, and maintain the Common Agreement. Through this effort, ONC will define the minimum required terms and conditions needed to bridge the current differences among data sharing agreements that are preventing the flow of electronic health information. The industry-based RCE will be tasked with developing additional required terms and conditions necessary to operationalize the Common Agreement and meet the interoperability requirements of the 21st Century Cures Act.

“The updated Trusted Exchange Framework and Common Agreement we issued today considered more than 200 comments we received on our previous draft and reflects extensive work with our federal partners,” said Don Rucker, National Coordinator for Health Information Technology. “The future Common Agreement, made possible by the steps we take today, will provide the governance necessary to meet the interoperability demands of diverse stakeholders, including patients, healthcare providers, and health plans.”

The drafts released are responsive to stakeholder comments by making key changes to the draft requirements that health information networks who choose to participate would have to follow. These changes include updating the purposes for which information can be exchanged, adding a “push” method of data exchange, adding a technical framework for QHIN’s, and extending timelines for participating entities to implement changes that will be required by the Common Agreement.

These changes will help improve the flow of information between networks where needed and appropriate. In public health settings, for example, “reporting from providers is a foundational capability for effective public health action,” said Chesley Richards, Deputy Director for Public Health Scientific Services at the Centers for Disease Control and Prevention & that “The TEFCA will not only strengthen this capability, but will create the ability for timely and true bi-directional information sharing that is essential for responding to public health threats and epidemics.”

Designed to fill the gaps that currently impede the secure and appropriate flow of health information and to continue to enable the progress that has already been made in the private sector, the success of TEFCA depends on coordination with the private sector. “We expect that the implementation of the Trusted Exchange Framework and the Common Agreement, will bring us all that much closer to achieving the administration’s goals of nationwide interoperability,” said Dr. Rucker.

General Data Protection Regulation (GDPR), One Year On

It is a very recent piece of legislation in the European Union and the European Economic Area regions (continuation to the previous article on GDPR in InnoHEALTH volume 3 issue 1 Jan-Mar 2018). The GDPR was adopted on 14th April 2016, and became enforceable on 25th May 2018. As the GDPR is a regulation and not a directive, it is directly binding and applicable, but does provide flexibility for certain aspects of the regulation to be adjusted by individual member states. the UK granted royal assent to the Data Protection Act 2018 on 23rd May 2018, which contains equivalent regulations and protections as the GDPR.

After the first year of implementation of the GDPR over 200,000 cases have been reported. European data protection agencies have issued fines in excess of 55 million Euros for GDPR breaches since it was enforced last May, but this seems to be just the tip of the iceberg, thus making a strong possibility that enormous number of GDPR breaches are occurring but probably are yet going unreported. An assessment from the European Data Protection Board (EDPB) which is made up of regulators across the region, found that, in the first nine months, there were 206,326 cases reported under the new law from the supervisor authorities in 31 countries in the European Economic Area. One thing that has changed since the implementation of the GDPR is the massive increase in the reported number of incidents and more importantly that the companies have been reporting themselves to the data commissioner over the past year. The main emphasis under the GDPR Regulation is that companies must notify the regulators very quickly once the company losses any personal data. Consequently, of the breaches huge fines can be levied on the companies if they are found to have not done what they should have done to protect the personal data or specifically be able to display that they did all they could to clean up after the breach occurred in the first place.

Considering the developments all around the world, in terms of guidelines and regulations, specifically relating to the digital health, it is only right & more essential to emphasize the pressing need for India to have specific laws too for this area as practice carries on while laws don’t exist, which will result in exponential damage in the coming times.

About the author

Sapna Singh is a lawyer with years of experience in Telehealth law research. She possesses Diploma in Hospital Administration from India; Masters of Law in Intellectual Property Rights from US; Masters of Science in Telemedicine & ehealth from UK.

The post WHO's First Guideline to Digital Health Interventions appeared first on InnoHEALTH magazine.

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

The post The Vulnerability of Medical Institutions to Cyber Attacks appeared first on InnoHEALTH magazine.

India EU Collaboration in Health Sector

InnoHEALTH Magazine — Fri, 16 Nov 2018 06:55:18 +0000

India EU collaboration in Health sector, startup opportunities, and challenges.

In this session, the panel provides insights on market development in India, including examples of reverse innovations from India to Europe and back along with legal and IPR challenges.

InnovatioCuris and InnovatioCuris Foundation for Healthcare and Excellence started with a vision of bringing down the healthcare delivery cost and improving the quality of care.

Some of the panelists represented EU member states or the EU entities and also from India on the panel. Their inputs were key in shaping up the cooperation between EU and India. Hence, Their inputs and early support has been key in shaping up the innovation ecosystem between the two regions.

Prof. Paul Lillrank (moderator) presented his keynote by giving insights of his ideas and implementations in the organization for which he is the chairman (Aalto Health Platform). Explained how the world famous, ARAVIND EYE CARE model was chosen and implemented by his student in Finland who studied ARVIND EYE CARE in Tamil Nadu. Stressed on technology circulation instead of technology transfer, as the later is only one directional flow. He felt India is the most innovative place in the world with the land full of opportunities.

Molshree Pandey, currently working on communicable diseases and finding ways to collaborate stakeholders in a much more efficient way. Conducts and concentrate on boot camps, road shows in Denmark, presentations to many companies; connecting and opening pathway to better delivery of care in India as well as Denmark. Insisted on modification of products according to the country.

Ankit Bahl compared the way of delivering care and implementing in 2 countries Estonia of 1.2 million populations with India of 1.2 billion populations. Estonian healthcare developments:

-Have S.E.Z for Pharmaceuticals, diagnostic companies in Estonia
-Worlds first biobank which Is commercialized too!
-97% of their patient prescriptions are made online for better access for both patients as well as stakeholder handling it.

Only three things can’t be made online in Estonia 1.marriage 2. Divorce 3. Trade property. Haha!! Introduced E ambulance in Estonia! They call E-Estonia and are also working towards to achieve it!

Iris Ohrn, A kind of matchmaker and identifies companies, investors which would benefit mutually. She observed similar challenges in India as well as Sweden in terms of the cost of healthcare.

K Gopalan, Works for the betterment of healthcare ecosystem of underprivileged. India is a big corridor for the scope of solutions. The focus needs to be on Primary health care, an example is vatsalya which is trying to provide subsidized private care. Promoted SANKALP, which is a form of the network of healthcare stakeholders.

Identification of right partners and right market recognition is required. IPR (very important) during technology transfer is at-most concerned.

As GDPR in EU, likewise, we need in India too. Shared her views on DISHA Act
DISHA:
– Setting up central and state organizations
– Ensuring trust in the system
– Recognition of ‘RIGHT TO RECTIFY’ by the patients is becoming important
Differences in DISHA and GDPR should be studied,
Example: right to forget/Erase isn’t there in DISHA

The post India EU Collaboration in Health Sector appeared first on InnoHEALTH magazine.

GDPR – General Data Protection Regulation

InnoHEALTH Magazine — Tue, 01 May 2018 07:31:06 +0000

General Data Protection Regulation (GDPR) is proposed by the European Parliament and Council to secure data and privacy of the citizens of European Union. It addresses the export of personal data outside the EU. The GDPR aims primarily to give control to citizens and residents over their personal data and to simplify the regulatory environment for international business by unifying the regulation within the EU.

The General Data Protection Regulation (GDPR) standardizes data protection law across all 28 EU countries and imposes strict new rules on controlling and processing personally identifiable information (PII). It also extends the protection of personal data and data protection rights by giving control back to EU residents. GDPR replaces the 1995 EU Data Protection Directive, and goes into force on May 25, 2018. It also supersedes the 1998 UK Data Protection Act.

This regulation GDPR applies to all organizations holding and processing EU resident’s personal data, regardless of geographic location. Many organisations outside the EU are unaware that the EU GDPR regulation applies to them as well. If an organization offers goods or services to, or monitors the behavior of EU residents, it must meet GDPR compliance requirements.

The aim of giving citizens more control over their information, GDPR ensures citizens can ask to access their data at “reasonable intervals”, with controllers having a month to comply with these requests. Both controllers and processors must make clear how they collect citizens’ information, what purposes they use it for, and the ways in which they process the data. The legislation also says that firms must use plain language to convey these things clearly and coherently to citizens: it’s time to wave goodbye to those confusing, dense terms and conditions.

Citizens have the right to access any information a company holds on them, and the right to know why that data is being processed, how long it’s stored for, and who gets to see it. Where possible, data controllers should provide secure, direct access for citizens to review what information a controller stores about them.

If a business suffers a data breach in the form of a loss, alteration of data, or unlawful access to personal information, such a breach needs to be reported to a Data Protection Authority within 72 hours of your organization becoming aware of it. If the breach results in discrimination, fraud or identity theft, financial loss, damage to reputation, loss of confidentiality of personal data, then the breach will need to be reported to the citizen as well.

Breaches can result in a fine of € 10M or 2% of a company’s annual revenue, whichever is greater. More serious breaches could result in a fine € 20M or 4% of a company’s annual revenue, whichever is greater. Apart from this, the Data Protection Authority can impose a complete ban on data processing operations by an organization.

One can also check similar article on Digital Information Security in Healthcare Act proposed by Indian government here.

The post GDPR – General Data Protection Regulation appeared first on InnoHEALTH magazine.