Table 1 Barriers affecting India's Telemedicine Exports to the EU
From: India-EU relations in health services: prospects and challenges
Constraint | Features and Implications |
|---|---|
Data protection, privacy, and information security issues[21] | • Bureaucratic EU data protection laws • Cumbersome database registration requirement with data protection authorities • Data on EU patients cannot be sent outside the EU unless legal basis for transfer, i.e., official adequacy finding to determine country has national laws to provide adequate level of data protection • India has not received adequacy determination from EU authorities, so needs to legalize data transfer • Lack of harmonization in data protection legislation among members creates additional compliance costs of security audits, fines, registration in signing contracts with clients in different EU member countries • Stringent national level legislations on data and information security and data privacy relating to disclosure and use of Protected Health Information create additional administrative, physical, technical, and organizational compliance costs (e.g., need to adopt information security standards along the lines of the British Standard for Information Security management, BS-7799) • Firms may need to set up commercial presence in EU and provide telemedicine from within EU to overcome the absence of data adequacy determination for Indian providers based in India |
Recognition and accreditation requirements | • Very expensive and time-consuming (as long as one year per provider) certification process • Multiple levels of verification with various professional bodies • Stringent certification requirements for teleradiology companies and providers • Registration required with each country's healthcare commission and concerned authorities • Compliance with EU directives on data protection, consumer safety, etc. • Indemnity/insurance requirement • Cumbersome evaluation and documentation requirements • Competence determination tests • Language requirements • Residency requirements • Requirement to appear in person for registration • Recertification, revalidation, re-licensure, regular appraisal requirements • Lack of harmonization within EU • Implicit discrimination against non-EU providers |
Contractual issues | • Practical problems with malpractice insurance and liability policies in EU countries • Handling of breach of contract and jurisdictional issues in enforcing compliance • Costs imposed due to service line agreement clauses on prior consent, indemnity, non-disclosure, liability • Delays in executing contracts |
Perception, attitudes, and stakeholder resistance | • Resistance to electronic delivery of healthcare in EU • Cultural and social barriers • Linguistic barriers, translation requirements for reports • Resistance from professional associations in EU due to concerns over employment losses |