The New E-commerce Regulation in India – Be a participant or an organizer, not both
Starting from February 1, 2019, Amazon India and Flipkart by Walmart, among others, are not allowed to hold inventory and sell to customers.
The rules now bar any entity in which an e-commerce firm or its group companies have a stake from selling on their online platform. This is a problem for Amazon, which had been picking up stakes in offline Indian retailers to boost its market share. (Reuters)
The Regulation In Four Dimensions
eCommerce in India can be broadly categorized as:
domestic and cross-border
B2B and B2C
marketplace and inventory based
single brand and multi brand
B2B: 100 percent FDI is allowed in companies engaged in B2B eCommerce, e.g. Walmart and Alibaba can operate a cash & carry (B2B) business.
B2C Marketplace: 100 percent FDI is allowed in the online retail of multi-brand goods and services B2C under the marketplace model, e.g. Amazon, Flipkart, Snapdeal. Any eCommerce entity providing a marketplace cannot exercise ownership over the inventory and is not permitted to sell more than 25 percent of total sales through its marketplace from one vendor to their group companies. There are also conditions restricting to offer discounts by marketplace.
B2C Inventory-Based: FDI is not allowed in inventory-based model of eCommerce.
Single Brand: A single brand retail trading entity operating through brick and mortar stores is permitted to undertake retail trading through eCommerce subject to local sourcing requirements. Food retail: 100 percent FDI is allowed for trading (including eCommerce) of food products manufactured or procured in India.
Multi-Brand Retail: No FDI is allowed in companies which engage in multi-brand retail trading by means of eCommerce.
E-commerce marketplace may provide support services to sellers in respect of warehousing, logistics, order fulfillment, call centre, payment collection and other services.
An e-commerce entity will not permit more than 25% of the sales value on financial year basis affected through its marketplace from one vendor or their group companies.
In marketplace model, any warrantee/ guarantee of goods and services sold will be responsibility of the seller.
E-commerce entities providing marketplace will not directly or indirectly influence the sale price of goods or services and shall maintain level playing field.
The government has also prohibited e-commerce firms from pushing merchants to sell any product exclusively on its platform. The sellers can, however, choose to have a preferred online partner.
Indian marketplace is dominated with many small shops and business. If foreign investment in multi-brand retail is to be permitted, then the business of these small shop owners will be in danger. Consumers will be spoilt with choices and due to high competitions, prices will go down, thus these multi-brand retail establishment will be able attract consumers at a large scale. However, in case of single-brand retail shops, they usually bring premium or luxury goods in the market so as such they are not in direct conflict with Indian small business. (blog.ipleaders.in)
Both are essential parts of running a successful business in health care.
An electronic health record (EHR) is a digital version of a patient’s paper chart. EHRs are real-time, patient-centered records that make information available instantly and securely to authorized users. (healthit.gov)
The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for sensitive patient data protection. Companies that deal with protected health information (PHI) must have physical, network, and process security measures in place and follow them to ensure HIPAA Compliance. (digitalguardian.com)
PHI is any demographic information that can be used to identify a patient. Examples include: names, dates of birth, Social Security numbers, insurance information, phone numbers, full facial photos, and health care records, to name a few examples. (compliancy-group.com)
A Short History
EHR Emerging in the 1970s
US federal government began implementing VistA (formerly known as the Decentralized Hospital Computer Program) at the Department of Veteran Affairs. A study by the Institute of Medicine (now National Academy of Medicine) began in the 1980s, and its findings recommended the use of EHRs when they were published in 1991. (readwrite.com)
The Health Insurance Portability and Accountability Act introduced in 1996
The Health Insurance Portability and Accountability Act (HIPAA) was passed on August 21, 1996, with the dual goals of making health care delivery more efficient and increasing the number of Americans with health insurance coverage. Since its implementation, healthcare organizations have been issued huge fines for non-compliance, e.g. Anthem $16 million HIPPA fine paid in 2018.
The Dilemma
Tough regulations were implemented before the applications (EHRs, etc.) grow into their best format/position in the healthcare system. The regulations made the softwares slow to upgrade/adjust themselves and prevented certain competitions.
EHRs are only an example of healthcare data regulated by HIPAA but a good one. It could have been a program like Apple Health Kit (on patients’ end) in the current era of well-designed apps like uber/gmail/amazon/instagram; but it was limited at the beginning stage and was left no time to refine itself. No wonder most parts are a vivid demonstration of tech/IT system some twenty years ago.
Left turn problem while driving, on the one hand, is so common that most people won’t think about it; on the other hand, it is so complicated and “evil” that remains mainly unsolved and avoided.
UPS avoided it
The most famous no-left-turn application is probably demonstrated by UPS. It’s route planner system ORION, based on heuristic algorithm, told UPS drivers not to turn left. Since 2004, turning right, plus other efficiency-optimizing efforts, has saved about 10 million gallons of gas and reduced emissions equal to taking more than 5,000 cars off the road for a year. (UPS)
The driver making a left hand turn will only have the right of way if they are proceeding on a left-turn arrow.
Otherwise, the driver turning left at a green light must wait until all oncoming traffic is gone or far enough away to allow for a safe and complete turn.
If a traffic light is not present, the left turning driver must still abide by the same precautions. The oncoming traffic will have the right of way and do not have to stop or slow down to allow left-turning drivers to pass.
Drivers making left turns must also wait for all pedestrians and cyclists are safely across the street before they can proceed with the turn.
This is why it is rare to find the other driver at-fault for this type of accident, and can be even more difficult to prove.
However with that being said, like anything, there are always a few exceptions to the rule.
The car driving straight was driving significantly over the speed limit when they were going through the intersection.
The car that is driving straight ran a red light or stop sign.
Unforeseen circumstances may warrant the other driver at-fault for the accident.
Self-driving car prototypes have been known to wait for long intervals at intersections before they finally made the left turn – heavily testing the patience of human drivers stuck behind them.
When a self-driving car hesitates at an intersection, the reason is not a problem with the algorithm but rather that the self-driving car finds that the safety margins for executing the turn are too small in the current situation: the risk is too high. Unfortunately, this problem can not be solved through better algorithms but only by increasing the level of acceptable risk! (driverless-future.com)
The Waymo vans have trouble with many unprotected left turns and with merging into heavy traffic in the Phoenix area, especially on highways. (The Information)
Since the new FDA Commissioner Dr. Scott Gottlieb was sworn in on May 11, 2017, the traditionally cumbersome regulatory body has shown an unprecedented embracement for novelty in treatments and beyond.
Novartis, Kymriah, first gene (transfer) therapy (first CAR-T) available in the United States
August 30, 2017
Biologics License Application (BLA) submitted on February 2, 2017
Approval basis: the safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL. The overall remission rate within three months of treatment was 83 percent. (FDA statement)
Pear Therapeutics, the Reset app, first mobile application to treat substance use disorders (SUD)
September 14, 2017
de novo premarket review pathway
Technology: the device delivers cognitive behavioral therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs. The system is intended to be used in conjunction with outpatient therapy and in addition to a contingency management system, a widely-used program for treating SUD that uses a series of incentives to reward patients for adherence to their treatment program.
Approval basis: a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of Reset which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used Reset, 40.3 percent, compared to the patients who did not, 17.6 percent. The clinical trial did not demonstrate the effectiveness of using the Reset device in patients reporting opioids as their substance of abuse. (FDA statement)
reSET app | Source: New York Times
Memorial Sloan Kettering Cancer Center, IMPACT test, first tumor-profiling laboratory-developed test to receive authorization through the FDA
November 15, 2017
de novo premarket review pathway
Technology: the IMPACT test uses next-generation sequencing (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor.
Approval basis: results indicated that the assay is highly accurate (greater than 99 percent) and capable of detecting a mutation at a frequency of approximately 5 percent (range of 2-5 percent). Additionally, detection of certain molecular changes (microsatellite instability) using the IMPACT test was concordant more than 92 percent of the time across multiple cancer types in 175 cases, when compared to traditional methods of detection.
Along with this authorization, the FDA is also establishing a Class II regulatory pathway for the review of other NGS-based tumor profiling tests for use in patients diagnosed with cancer. Class II designation allows these types of tests to be eligible to use the FDA’s 510(k) clearance process, either by submitting the application. (FDA statements)
Source: mskcc.org
Proteus Digital Health x Otsuka Pharma, Abilify MyCite, first drug in the U.S. with a digital ingestion tracking system
November 13, 2017
New Drug Application (NDA) dated and received June 26, 2015
Technology: the system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
Approval basis: Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. (FDA statement)
Source: npr.org
Spark Therapeutics, Luxturna, first (directly administered) gene therapy approved in the U.S. to target a disease caused by mutations in a specific gene
December 19, 2017
Biologics License Application (BLA) dated April 26, 2017, and received May 16, 2017
Approval basis: The efficacy of LUXTURNA in the Phase 3 study was established based on the multi-luminance mobility test (MLMT) score change from baseline to one year. LUXTURNA Phase 3 clinical study results showed a statistically significant difference between the intervention group (n=21) and control participants (n=10) at one year in median bilateral MLMT score change (intervention minus control group difference of 2; p=0.001) and median first-treated eye MLMT score change (intervention minus control group difference of 2; p=0.003). (Spark press release)
Apple, the ECG app (with Apple Watch), first FDA clearance for retail ECG watch technology
September 11, 2018
De Novo clearance from the Center for Devices and Radiological Health, classified as Class II under the generic name electrocardiograph software for over-the-counter use
Technology: the ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform
January 17, 2019 update: Alphabet’s life sciences unit Verily received 510(k) clearance from FDA as a Class II medical device for its on-demand ECG feature
Just two days ago, one of the most popular growing app China “Douyin/Tiktok” (owned by ByteDance, formerly known as Toutiao) was founded to be blocked to login with WeChat (owned by Tencent) for new users.
The two old king in social apps is fighting the rising new star.
In March 2018, WeChat global MAUs surpassed 1 billion.
Douyin said its global MAUs is over 500 million in July 2018.
Source: Inkstone, July 2018
Tencent’s WeChat has been on the market way earlier (since 2011). Douyin was launched in Sep 2016 but its growth has been so terrifying that Tencent has adopted several defensive actions, including blocking sharing Douyin links in WeChat.
Tencent has also backed Qutoutiao to combat with Jinri Toutiao (Toutiao’s flagship and first product) and Weishi for Douyin.
Now the war has escalated. Toutiao launched a new social app “Duoshan” to challenge the King and Tencent blocked WeChat login for Douyin.
Duoshan App | Source: TechCrunch
Things are just getting started. But it reminded me of the 3Q war in 2010 between Tencent and Qihu360. Tencent didn’t have WeChat yet and relied on its QQ platform (the previous King).
Tencent vs. Qihu360 | Source: tech.sina.com.cn
During the war, one particular action by Qihu was seen by Pony Ma (Tencent founder and CEO) as the most threatening and he forced users to log off QQ if they don’t uninstall Qihu.
The key in that situation and in Ma’s mind is the copy of social map. The full connections between almost every relevent Chinese internet user.
This is probably what Ma values most and is one of Tencent’s core secrets.
That is what Toutiao is trying to obtain with Duoshan and Douyin today ina different way than Qihu) – the social map of almost every relevant Chinese (young) mobile users. And those would be the future Chinese internet revenue sources/assets/reserves.
The war will continue to unfold and Toutiao is much more powerful than Qihu. Toutiao is one of the most valued private companies in the world, but it is also taking on Baidu for news feeds and ads – multi-battleground just like Uber.
