Thursday, June 16, 2016

Healthcare Business And Industry Of India Would Be Benefitted By Proposed Modern Laws

Healthcare related laws of India are very old and they have not kept pace with the contemporary requirements. In an online world, traditional laws are more hindered than solution. This is the reason why we need to amend or even repeal the same and substitute them with appropriate techno legal laws. In one such initiative the Central Drugs Standards Control Organisation (CDSCO) is working towards drafting a new Drugs and Cosmetics Act, 2016 and a Medical Devices Act, 2016.

Medicines and medical devices are in existence for many years. Information and communication technology (ICT) has changed the way medicines and medical devices were sold in old times. Even medical devices have assumed a totally different identity with the introduction of smart technology and artificial intelligence. Now smart gadgets have connected individuals with hospitals, clinics and family doctors in a 24 x 7 x 365 mode. Health related data and information is available in real time to both doctors and the patients that has significantly improved the health of patients as remedial measures can be taken well in advance based on the data provided by smart e-health gadgets.

However, laws in India are lagging far behind and they are not compatible with the concepts like e-health, telemedicine, m-health, online pharmacies, etc. Further, India has still not enacted necessary dedicated laws for cyber security, privacy, data protection (pdf), online pharmacies, Ayurvedic preparations, etc without which Indian healthcare industry cannot grow and survive. Indian e-health and medical device manufacturers are also not complying with techno legal requirements like cyber law due diligence (pdf), encryption laws, etc. If we wish to incorporate e-health, m-health and telemedicine into a smart city model, then we have additional techno legal compliances that must be ensured.

Indian government is in the process of removing redundant and outdated laws and enacting new one as per contemporary requirements. Healthcare industry is also on the priority list of Indian government for legislative business. For instance, the Central Drugs Standards Control Organisation (CDSCO) is working towards drafting a new Drugs and Cosmetics Act, 2016 and a Medical Devices Act, 2016. The move follows after the ministry of health and family welfare initiated steps to revisit the D&C Act 1940 and Rules 1945. The objective of this step is to enact contemporary laws that can ensure safety, efficacy and quality of drugs and medical devices.

The director (Admin) of Central Drugs Standards Control Organisation (CDSCO) has on June 6, 2016 asked all state drugs controllers to give feedback based on their experience within 15 days from the said notice. There have been several transformations like new brands, biologicals and biotech drugs besides the fixed dose combinations that need a set of dedicated rules. These rules are also relevant keeping in mind the regulatory requirements of different countries where Indian medicines and medical and healthcare products are exported.

For instance, recently the United States Food and Drug Administration (U.S. FDA) issued an Import Alert 66-40 (pdf) titled Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs. This alert deals with detention without physical examination of drugs from firms which have not met drug good manufacturing practices (GMPs). Many Indian pharmaceutical companies have been listed on this alert and import from them has been banned. In fact, Lupin has recalled 9,210 bottles of Suprax drugs for failure to pass purity test.

Border enforcement of intellectual property rights (IPRs) by countries including European Union has also posed problem for Indian pharmaceutical and healthcare companies. EU and India even decided to sign a letter of understanding to protect off patent generic drug consignments. Further, due to policy decisions of United States, Novartis AG’s heart drug Diovan was also kept out of patients reach. This is despite the fact that Indian patent law is in conformity with WTO and international obligations. Expiring medicine Patents can boost pharmaceutical business and e-commerce as the generic pharmaceutical companies can provide affordable drugs in large quantity. 

The Drugs and Cosmetics Act & Rules 2016 will try to ensure compliance with some of these issues by the Indian pharma industry. There is also the introduction of Central Licensing Authority (CLA) along with State Licensing Authority (SLA) and Central Licensing Approval Authority (CLAA) for Schedule III drugs in the last year's Amendment Bill. The new regulations may also cover the Uniform Code for Pharma Marketing, Formation of Task Force to formulate bulk drug policy, medical devices policy, creation of price monitoring and resource units in the state drugs control department.

Tuesday, May 24, 2016

Recognition Of Foreign Divorce Decree In India

Recognition of foreign divorce decree in India is a complicated conflict of law principle. This is because the marriage is solemnised in one country and the divorce is obtained from another country. In the Indian context, a marriage is solemnised in India and a divorce decree is obtained from a foreign jurisdiction, especially United States or United Kingdom. The reason for this dual proceedings is because in India marriage is considered to be a sacrament and divorce is not easily obtainable. Of course, where mutual consent is involved, there is little trouble in dissolution of a marriage in India.

However, where the fault theory is invoked or where one party is interested in divorce whereas the other is not, it takes years for the party seeking divorce to get the same. Some individuals have devised a mechanism of forum shopping and they seek divorce from jurisdictions where it can be obtained easily.

The Supreme Court of India has given a constructive interpretation to the existing laws and provisions of India to decide when such a foreign divorce decree can be held to be valid and legal in India. This is so because the matrimonial laws are not common everywhere in the world and they differ from country to country. The problem arises when the parties have their domicile in one country and one of them obtains matrimonial relief in a foreign country. A large number of foreign decrees in matrimonial matters are becoming the order of the day. Similarly, illegal domicile certificates are also very common these days to get benefits of conflict of laws in areas like inheritance, taxation and divorce.

India’s social, moral and religious conditions, along with the “public policy”, will be decisive for determining the matrimonial law, including jurisdictional aspects, applicable in India and the harmonisation of law cannot be achieved at the cost of their ignorance and sacrifice. The courts can refuse to apply a rule of foreign law or recognise a foreign judgment or a foreign arbitral award if it is found that the same is contrary to the public policy of the country in which it is sought to be invoked or enforced.

Under Section 13 of the the Code of Civil Procedure, 1908 (Code), a foreign judgment is not conclusive as to any matter thereby “directly adjudicated upon” “between the parties” if:

(a) it has not been pronounced by a Court of competent jurisdiction; or

(b) it has not been given on the merits of the case; or

(c) it is founded on an incorrect view of international law or a refusal to recognize the law of India in cases in which such law is applicable; or

(d) the proceedings are opposed to natural justice, or

(e) it is obtained by fraud, or

(f) it sustains a claim founded on a breach of any law in force in India.

It is thus clear that in order to make a foreign judgment conclusive in India; it must be shown that it complies with all the abovementioned six conditions. If there is no compliance of any one of these conditions, the foreign judgment will not be conclusive and consequently not legally effective and binding. A decree of a foreign Court is normally recognised by a Court in another jurisdiction as a matter of comity and public policy. But no country is bound to recognise and give effect to a decree of a foreign Court if it is repugnant to its own laws and public policy. So far as India is concerned, a judgment of a foreign Court creates estoppel or res judicata between the same parties provided such judgment is not subject to attack under any of the Clauses (a) to (f) of section 13 of the Code.

Ultimately, it is a question of fact that decides whether a foreign divorce decree can be enforced in India or not. Further, advent of information and communication technology (ICT) has added further complications for recognition of foreign divorce decrees in India. Thus, only trained legal professionals who are well versed in marriage and divorce, conflict of laws principles and techno legal issues can best help in this regard.

If you are interested in our techno legal expertise regarding solving your conflict of laws issues, please establish a client attorney relationship so that we can assist you in your matters.

Monday, May 23, 2016

Salient Features Of The Nagaland Prohibition Of Gambling And Promotion And Regulation Of Online Games Of Skill Act 2016

Recently the Nagaland Prohibition of Gambling and Promotion and Regulation of Online Games of Skill Bill, 2015 (“Bill”) was made an applicable law. Now the government is in the process of formulating rules for the same. Perry4Law Organisation (P4LO) has contacted the Nagaland government and has requested for the official documents in this regard so that we can share the same with gaming stakeholders. For the time being, Perry4Law Law Firm has provided an analysis of the Nagaland Gaming Act, 2016 based on the publicly available information and inputs. Please see the Nagaland Prohibition of Gambling and Promotion and Regulation of Online Games of Skill Bill 2015: Salient Features (pdf) for the complete analysis.

Some of the salient features of the Nagaland Gaming Act, 2016 are as follows:

(1) The Act allows games of skills and prohibits games involving gambling elements.

(2) Some games have been specifically included in games of skill and this would reduce the confusion about the nature of gambling activities. However, inherent conflicts and inconsistency is there in the provisions of the Act and this would create problems for the gaming stakeholders in future.

(3) Severe fines have been prescribed by the Act for gambling activities. For instance, a fine of Rs 20 lakhs will be applicable in the first instance, followed by an imprisonment of 6 months if not remedied further.

(4) Games which have been declared by courts (Indian or International) as games of skill may be included in this list in future. The Finance Commissioner or any Licensing Authority will be permitted to add to this list the games of skill as long as it is in consonance with the definition of ‘Games of Skill’ under the Act.

(5) The Act applies to any territory in India in which “games of skill” are permitted and are recognised as being exempt from the ambit of “gambling”.

This would raise serious legal issues as till now the legality of games like online poker, online rummy, e-sports, fantasy sports, online card games, online fantasy games, online lotteries, etc is not clear.

P4LO has been managing a Blog titled Online Gaming And Gambling Laws And Regulations In India to help online gaming and online gambling stakeholders of India and other jurisdictions. This Blog can be used as a guidance by the gaming stakeholders and if they need our techno legal professional assistance, they can establish a client attorney relationship and seek our services.

(6) Indian place of business and Indian connections are essential for getting a licence from the Nagaland government. An interest in any online or offline gambling activities in India or abroad would bar an individual or entity from getting the licence.

(7) The State Government, may, by notification, designate an authority or body to monitor and regulate the activities of all licensees to ensure compliance with the provisions of this Act, and to settle all disputes arising from the activities conducted under this Act

(8) If the licensee operates in a state where the state government believes the company is violating the provisions of the act or its rules, or in violation of local laws, it may inform the licensing authority of Nagaland. The licensing authority shall then try and get the issues resolved.

P4LO welcomes this legislation from Nagaland government. However, there are certain techno legal issues that have skipped the attention of government of Nagaland. It would be prudent to cover those issues before the rules are notified by the Nagaland government.

Sunday, May 22, 2016

Legal Compliances For Running An Online Fantasy Sports Website In India

A very frequent question that is asked from Perry4Law Law Firm pertains to legal issues of fantasy sports in India. We have already covered this issue in our latest article titled legality of running and playing online fantasy sports in India.

Just like any other online games, entrepreneurs engaged in fantasy sports in India are also required to comply with certain techno legal requirements. There is a need to change the mindset of online games entrepreneurs who are still not serious about legal issues in India. Even if some are interested in complying with the legal requirements of online gaming they are ill advised and do not comply with Indian laws properly.

The problem stems from the fact that there is no clear regulatory framework that can be looked upon to decide legality or illegality of online poker, online rummy, online card games, fantasy sports, etc in India. On the other hand, regulatory compliances are scattered among different laws of India and combining them together at a single place is a big challenge. Unfortunately, online gaming and fantasy sports websites in India are not complying with these techno legal requirements and they are on the wrong side of Indian laws.

As on date, online gaming, online gambling, fantasy sports and online lotteries websites are not complying with the internet intermediary compliances and cyber law due diligence (pdf) requirements prescribed under the Information Technology Act 2000. Similarly, almost all of the online poker websites in India are violating one or other laws of India. Although online gaming market in India is booming yet regulatory compliances cannot be ignored. It seems online gaming and online gambling industry of India is not considering regulations while conducting their businesses in India.

Perry4Law conducted a techno legal audit of various fantasy sports websites operating in India and we found the same problems with them as have been discussed above. Almost all of these fantasy sports websites have used a single cut-copy-paste criteria when it comes to techno legal compliances and drafting of legal documents of the websites. Clearly, these online fantasy sports websites are violating the laws of India and they may be prosecuted very soon. Those using mobile applications can also be prosecuted if they fail to comply with techno legal regulatory norms of India.

Even the banks, payment gateways and online payment merchants, mobile payment vendors, etc supporting these online poker, online rummy, online card games and fantasy sports websites can be held liable for not following cyber law due diligence norms as they have blindly approved online payment option to these illegal and law breaking websites. These banks and payment gateways can also be held liable for money laundering, FEMA violations and assisting in tax evasion. If such banks, payment gateways and online payment merchants have already approved such illegal and law breaking online poker, online rummy, online games and fantasy sports websites in India, it is in their own interest to cancel such approval immediately. The banks etc must ask them to first comply with applicable techno legal compliances and then support their claims with a proper techno legal consultancy from a reputed law firm.

If you need a techno legal compliance and legal consultancy from Perry4Law for your online games or fantasy sports, please establish a client attorney relationship so that we can start working upon your project. Perry4Law wishes all the best to all gaming stakeholders and entrepreneurs.

Thursday, May 19, 2016

National E-Health Authority (NeHA) Of India Proposed

Healthcare laws and regulatory compliances are long overdue in India. For instance, telemedicine and online pharmacies related regulatory issues are ignored by the e-health and m-healthy entrepreneurs in India. Websites selling medicines online are openly flouting the laws of India. Mobile application developers in India are also required to comply with privacy, data protection and cyber law requirements. These regulatory compliances are not adhered to by healthcare industry and entrepreneurs of India.

Similarly, healthcare cyber security issues in India are still not priority area for businesses and entrepreneurs. Healthcare industry is facing diverse range of cyber attacks these days. The prominent among them is ransomware that encrypts the sensitive healthcare information and decrypts the same only once the ransom is paid. So much is the nuisance these days that the National Institute of Standards and Technology (NIST) has released a guide for IT developers on integrating security measures into the development process, which could influence healthcare cyber security management.

Recently the cabinet approved the draft national IPR policy of India. This would facilitate intellectual property creation in favour of e-health and m-health entrepreneurs in India. This would also ensure that IPRs of others are not violated by the e-health and m-health entrepreneurs of India

Indian government has started ambitious initiatives like Digital India and Internet of Things (pdf) that intend to bridge the digital divide in India on the one hand and enabling e-delivery of services in India on the other. There are many segments of Digital India projects and e-health is one of them. E-health initiatives of India government aim at providing timely, effective and economical healthcare services to Indian population. E-health is particularly relevant for masses that have little access to healthcare services in India.

While the objectives of Digital India are laudable and deserve full support yet we at Perry4Law Organisation (P4LO) also believe that the shortcomings of Digital India project of India cannot be ignored or bypassed by Indian government. Similarly insisting upon Aadhaar number for healthcare services in India would be a terrible idea especially when Aadhaar is not mandatory for government services in India.

A proposal to constitute an e-health authority of India was mooted in June 2014. Now the Ministry of Health and Family Welfare has released a concept note discussing establishment of the National eHealth Authority (NeHA) for India. According to the note, NeHA will be the nodal authority that will be responsible for development of an Integrated Health Information System (including Telemedicine and mHealth) in India, while collaborating with all the stakeholders, viz., healthcare providers, consumers, healthcare technology industries, and policymakers. It will also be responsible for enforcing the laws and regulations relating to the privacy and security of the patients health information and records.

As per the concept note, NeHA would be responsible:

(a) To guide the adoption of e-Health solutions at various levels and areas in the country in a manner that meaningful aggregation of health and governance data and storage/exchange of electronic health records happens at various levels in a cost-effective manner,

(b) To facilitate integration of multiple health IT systems through health information exchanges,

(c) To oversee orderly evolution of state-wide and nationwide Electronic Health Record Store/Exchange System that ensures that security, confidentiality and privacy of patient data is maintained and continuity of care is ensured.

In the light of the above, NeHA has been envisaged to support:

(a) Formulation of policies, strategies and implementation plan blueprint (National eHealth Policy / Strategy) for coordinated eHealth adoption in the country by all players; regulation and accelerated adoption of e-health in the country by public and private care providers and other players in the ecosystem; to establish a network of different institutions to promote eHealth and Tele-medicine/remote healthcare/virtual healthcare and such other measures;

(b) Formulation and management of all health informatics standards for India; Laying down data management, privacy & security policies, standards and guidelines in accordance with statutory provisions; and

(c) To promote setting up of state health records repositories and health information exchanges (HIEs);

(d) To deal with privacy and confidentiality aspects of Electronic Health Records (EHR).

Functions of National eHealth Authority

(1) Core Functions

(a) Policy and Promotion

(i) Working out vision, strategy and adoption plans, with timeframes, priorities and road-map in respect of eHealth adoption by all stakeholders, both Public and Private providers, formulate policies for eHealth adoption that are best suited to Indian context and enable accelerated health outcomes in terms of access, affordability, quality and reduction in disease mortality & morbidity

(ii) To engage with stakeholders through various means so that eHealth plans are adopted and other policy, regulatory and legal provisions are implemented by both the public and private sector stakeholders.

(iii) It shall provide thought leadership, in the areas of eHealth and mHealth.

(b) Standards Development

(i) Government of India, MoHFW has published EMR/EHR standards for India in 2013. Similarly, MoHFW has become a member of IHTSDO with a view of widespread adoption of SNOMED-CT in India; MoHFW has also nominated C-DAC (Pune) as interim NRC (iNRC). As such, initial focus of NeHA would be on addressing implementation issues and promoting mechanisms in support of the same.

(ii) Concurrently, NeHA will be nurtured to undertake the role of a standards development, maintenance and support agency in the area of Health Informatics

(c) Legal Aspects including Regulation

(i) NeHA will be setup through an appropriate legislation (Act of Parliament). It is also proposed to address the issues relating to privacy and confidentiality of Patients’ EHR in the legislation. NeHA may act as an enforcement agency with suitable mandate and powers.

(ii) NeHA will be responsible for enforcement of standards and ensuring security, confidentiality and privacy of patient’s health information and records.

(d) Setting up and Maintaining Health Repositories, Electronic Health Exchanges and National Health Information Network

NeHA, while avoiding the implementation role by itself, will prepare documents relating to architecture, standards, policies and guidelines for e-Health stores, HIEs and NHIN; it may also initiate or encourage PoCs, in close consultation with government – centre and states, industry, implementers and users. Later, it would lay down operational guidelines and protocols, policies for sharing and exchange of data, audit guidelines and the like; these shall be guided by experience in operation and use of PoC, global best practices and consultations with stakeholders (MoHFW, State governments and other public and private providers, academia, R&D labs, and others).

(e) Capacity Building

Spreading awareness on Health Informatics / eHealth to healthcare delivery professionals through various educational initiatives and flexible courses according to the background of the learners will form a component of NeHA activities, as it is seen as critical to acceleration of adoption of eHealth.

(f) Other functions may be assigned to NeHA as the situation warrants.

Health being a state subject in India and much depends on the ability /regulatory framework enacted by the State governments, NeHA shall be created through legislation (Act of Parliament) that empowers it to take leadership and strategic role for setting directions for public and private eHealth initiatives, including electronic health records storage and health information exchange capabilities and other related health information technology efforts and regulation of the same.

NeHA shall ensure ongoing interagency cooperation – while engaging with various stakeholders through the Standing Consultative Committee and also through other means, in a structured, open and transparent manner to support successful evolution of national integrated health information system. We at P4LO welcome this initiative of Indian government and wish all the best to it in this regard.

Wednesday, May 18, 2016

Mobile Gaming Market And Business In India And Legal Issues And Challenges

Mobiles have become ubiquitous in India and they are practically being used for every aspect of our day to day activities. Mobile gaming is just one example of use of mobiles by Indians. However, use of mobile have given rise to very complicated techno legal issues that require a techno legal framework to manage them. The truth is that mobiles and mobile related activities cannot be handled by the Information Technology Act, 2000 (IT Act 2000) anymore and we need dedicated mobile phone laws in India. This is more so when the mobile gaming market in India is fast growing.

Gaming industry of India was confined till recently to physical games only. However, with the advent of information and communication technology (ICT), Internet based and mobile games have fast emerged. For instance, online rummy, online poker, online card games, etc are very popular these days. Even online lotteries have become very common these days in various states of India. However, online gaming industry of India received a major setback when both the Central Government and Supreme Court of India refused to clarify upon the legality of online games in India.

As per the research and reports of various organisations, online gaming and mobile gaming market of India is set for big growth. Many foreign companies have also shown their interest in exploring the Indian gaming market. However, only those stakeholders would be benefited from the same who are in compliance with the techno legal requirements of mobile gaming laws of India. Besides techno legal issues, online gaming and mobile gaming providers would also be required to introduce the element of “localisation” to make their online games successful. Text translation, dialogue dubbing and character outfits are among the most common tweaks in the “localisation” work by firms wanting to capitalise on Asia’s booming online gaming market. However, the term localisation is not confined to mere commercial aspects but it covers legal issues as well. This means that local laws are also required to be complied with by Indian and foreign online gaming service providers.

Many global gaming entities have also opened offices in India or have signed distribution agreement with leading Indian mobile game developers to distribute their products in India. While operating gaming business is easier in some countries of the world where gaming is legalised yet the situation is not so easy in India where the laws are stringent. India is still struggling to deal with issues of mobile payments and mobile application development laws and this has further complicated the scene.

The Constitution of India empowers the State Legislatures to frame state specific laws on betting and gambling under the List II, Entry No. 34 of Seventh Schedule. The Public Gambling Act, 1867, is a central enactment on the subject, which has been adopted by certain states of India. The other states in India have enacted their own legislation for regulating gaming activities within its territory. However, this was an easier task for the states as most of these laws were made applicable to physical games that could be easily confined to the territories of a particular state. Internet and ICT has obliterated this territorial limits and now online or mobile gaming activities of a state can be made available to another state. This not only is illegal but is also a direct violation of the legislative powers of the states who do not allow such online or mobile games.

Many online games or mobile games entrepreneurs believe that physical games legal concepts and judgments can be automatically applied to online games or mobile games. However, this is a wrong assumption and can give rise to various forms of legal prosecutions. We at Perry4Law Law Firm firmly believe that online games and mobile games are totally different from physical games and it is a serious legal fallacy to blindly apply the test of skills v. chance to online or mobile games. The test is just one of the factors and relying solely upon this test would surely attract legal sanctions.

There are very few players as on date in the mobile gaming industry of India. However, these players have to resolve many techno legal issues before they can establish their businesses in India. These include mobile payment compliances, payment gateway and POS terminal service due diligence, websites development compliances, Internet intermediary obligations, cyber law due diligence (pdf), etc.

Perry4Law strongly recommends that online and mobile gaming entrepreneurs and businesses in India must ensure techno legal compliances before launching their respective ventures in India. Avoiding these techno legal compliances would prove counter productive in the long run.

Saturday, May 14, 2016

Healthcare Laws And Regulatory Compliances In India

Legal and regulatory issues of technology and technology driven projects have always vexed governments around the world. India is no exception to this fact as Indian government is still struggling to deal with the legal issues of fields like e-health, m-health, telemedicine, etc. Similarly, many healthcare services are dependent upon cloud computing these days. The legal and regulatory issues of cloud computing in India are far from satisfactory. As a result many businesses and companies are hesitant in using the same for various purposes including for healthcare purposes.

On the positive side, the Electronic Health Record (EHR) Standards of India have been prescribed and establishment of a National E-Health Authority (NeHA) of India has also been proposed by Indian government. Further, if we remove the shortcomings of Digital India project then the same can be used for e-health and healthcare purposes as well.

Technology vendors and entrepreneurs are eying upon Indian healthcare market as the same is booming and has great commercial significance for the coming decades. However, along with benefits there are liabilities and obligations as well. For instance, e-health, m-health, telemedicine, etc are subject to techno legal compliances. Presently the healthcare industry and healthcare entrepreneurs of India are acting more on the side of violation than compliances.

The legal risks for developer and owners of healthcare websites cannot be ignored. Further, mobile medical devices and handsets and their respective applications must also be in strict conformity with Indian laws. Medical device makers, software providers and medical fraternity of India must also keep in mind the encryption laws of India and cloud computing related legal risks in India.

For instance, AIIMS Bhubaneswar has recently launched electronic health card system and other hospitals and clinics may also adopt this practice. However, issues of privacy rights, data protection (pdf), cyber security, data security, cyber security breach reporting, biometric collection compliances, etc have still not been addressed and complied with by hospitals, clinics and Indian government. Even the Parliamentary Committee slammed Indian government for poor privacy laws and privacy protection in India.

Similarly, there are very complicated sets of legal requirements for establishing online pharmacies in India and for online sale of prescribed medicines in India. We have no dedicated laws for opening of online pharmacy stores in India but different laws of India govern different legal aspects of the same. There are numerous legal risks associated with online selling of medicines in India and all online pharmacies that intend to operate in India mist strictly follow various regulatory provision related to this field. As on date online pharmacies in India are violating various applicable laws of this field.

In the Indian context, regulatory compliances are frequently ignored and violated. Whether it is online pharmacies, e-health, m-health, telemedicine, mobile medical devices and applications, etc, medicine field related stakeholders are openly flouting the applicable norms and regulations.

Although we have no law on the lines of United State’s Health Insurance Portability and Accountability Act of 1996 yet there are numerous statutory provisions that must be complied with. These include privacy law compliances, data protection requirements, cloud computing compliances, encryption related compliances, cyber law due diligence (pdf), etc.

Clinical establishments operating in India are also required to comply with the requirements of the Clinical Establishments (Registration and Regulation) Act 2010 (pdf) and the Clinical Establishments (Central Government) Rules 2012 (pdf). Further, Recommendations on Electronic Medical Records Standards in India (pdf) have also been prescribed that have to be followed and complied with by Indian clinics and healthcare professionals of India. Perry4Law Organisation (P4LO) strongly recommends that both national and international healthcare stakeholders must ensure techno legal compliances of this field. Non compliance would bring not only bad publicity for them but may also result in civil and criminal prosecutions.