Intellectual property

Digital healthcare is basically a combination of the digital usage of healthcare programs which further has the aim to improve society’s health and healthcare

Intellectual propertyWhat is Digital Healthcare?

Digital healthcare is basically a combination of the digital usage of healthcare programs which further has the aim to improve society’s health and healthcare as well as the delivery of care and make it more individualized and precise.

The use of information and communication is used to address the problems that citizens have with their health and the dynamics of healthcare. The digital healthcare system consists of both software and hardware technologies and ranges from monitoring sensors to mobile apps to website-based analysis. 

The impact of Medical professionals’ data circulation –

Positive

  • Improved care quality- achieved through the performance of seamless contact between medical professionals. 
  • Coordination – By using a digital healthcare system, it is simple to access experts and to bridge the gap between developed areas and rural or underdeveloped areas. 

Negative

  • Training and education – Due to the digitization of everything, medical professionals will now need to undergo training before performing any tasks. 
  • Data ownership – Since there is no clear explanation or precise ownership upon the information, determining the ownership of the data or information that is generated and circulated can be problematic. Clarifying the rights is essential for improving user accountability and trust. 

Legal issues in digital healthcare

Both patients and providers will experience a change in the playing field because of emerging technologies like telemedicine, digital health apps, and information sharing. However, as a result of increased communication, there are more threats to the security and privacy of patient information. Data security and privacy violations are a major concern for many telemedicine and digital health businesses. Additionally, sharing protected health information (PHI) with third parties on purpose, whether for data mining, analysis, or marketing purposes, is possibly a bigger enforcement concern. In the healthcare sector, where data sharing and data mining are expected to increase, providers and vendors are aware of the appropriate times and methods for exchanging PHI.

Concerns for usage

  1. Data use – Concerns over data security are important when using personal data. The Electronic Health Record Standards (EHR Standards) for India were announced by the Ministry of Health and Family Welfare (MoHFW) in September 2013. These were chosen based on their suitability and applicability in India from among the best currently available, widely accepted standards applicable to international electronic health records. As a result, healthcare providers and organizations from around the world are informed of and invited to submit their IT systems for integration with the EHR Standards 2016 framework. The Systematised Nomenclature of Medicine Clinical Terminology (SNOMED CT) and the Interim National Release Centre were designated by MoHFW to adhere to the clinical terminology standard that is increasingly being accepted by the healthcare industry in order to promote its adoption.The MoHFW intends to establish a legislative body in the shape of a national digital health authority through the proposed DISHA to promote and adopt e-health standards, implement privacy and protection provisions for electronic health data, and manage the storage and sharing of electronic health records. 
  2. Intellectual property – Innovative products have been developed in the digital health sector. It is crucial to protect certain innovations and ideas in this fiercely competitive market. The IPR law of India offers various avenues for this protection, including patents, copyrights, trademarks, and designs. Production in the context of digital applications (including mobile apps) and wearable technology is prioritized. This section discusses the various types of IP protection readily accessible as a result of such developments.
  3. Patents – If a device or system is determined to be “a method for the medicinal or other treatment of humans and animals” in accordance with Section 3(i) of the Patent Act (which deals with things that aren’t exactly inventions), a patent won’t be granted. A device for the detection of HIV antibodies and p24 HIV antigen in human serum or plasma was discovered to be outside the scope of section 3(i), according to the patent examiner’s observations, which make a distinction between a device and a process.
  4. Copyright – Clinical guidelines and data may be protected by the Copyright Act if they are presented in a media format. A pure collection of data without any further effort is not protected by copyright law. This is based on the ‘sweat of the brow’ doctrine, which states that even though content like tables or databases may not be entirely original, copyright can only be protected if an individual makes an independent effort to gather the data. The individual is then entitled to compensation for his or her expenses and efforts.
  5. Trademark -In addition to statutory protection, common law also provides protection for unregistered marks. A “mark” has been defined as “a device, a brand, a heading, a label, a ticket, a name, a signature, a word, a letter, a number, a product shape, a packaging or a color combination or any combination thereof” under the TM Act. The ‘label’ of a Digital Health application or device may be registered as a trademark under the TM Act, subject to a few exclusion criteria that serve as grounds for refusal of the trademark, such as the absence of distinctive character or marks or indications that have become commonplace in the current lingo or accepted commercial practice. 

Regulations and legislations Reimbursement

Regulation and legislation are crucial to the reimbursement process in the digitized healthcare industry. Regulations and legislation are crucial to reimbursement in the digital healthcare industry. the usage of digital health technologies, healthcare providers must follow the reimbursement policies set by government agencies. These rules make sure that remote monitoring and telemedicine services are fairly compensated, encouraging their uptake. The necessity of following these regulations in order to be reimbursed encourages healthcare organizations to make investments in digital solutions. Additionally, laws frequently change to reflect new technologies and requirements for patients, necessitating constant updating and practice modifications on the part of healthcare providers in order to maintain their eligibility for payment in the era of digital healthcare.

A proposed authority called the National Digital Health Authority (NeHA) of the Ministry of Health and Family Welfare is also in charge of developing an integrated health information system for India. It is suggested that it serves as a body that promotes, regulates, and establishes standards to guide India’s journey towards digital health and the ensuing realization of ICT benefits in the health sector.

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